Systems, methods, and devices for applying distributed forces for mandibular advancement

ABSTRACT

Improved systems, methods, and devices for treating sleep apnea are provided herein. In one aspect, an intraoral appliance for treating sleep apnea in a patient comprises an appliance shell comprising a plurality of cavities shaped to receive teeth of a jaw of the patient. The appliance shell can comprise an advancement structure arranged to interact with an opposing jaw of the patient so as to displace the lower jaw anteriorly relative to the upper jaw. The plurality of cavities can comprise cavity geometries shaped to reduce repositioning of one or more received teeth elicited by displacement of the lower jaw anteriorly relative to the upper jaw.

CROSS-REFERENCE

This application is a continuation of U.S. patent application Ser. No.14/992,325, filed Jan. 11, 2016, now U.S. Pat. No. 10,588,776, issuedMar. 17, 2020, which claims the benefit of U.S. Provisional ApplicationNo. 62/103,005, filed Jan. 13, 2015, and U.S. Provisional ApplicationNo. 62/161,786, filed May 14, 2015, the disclosures of each of which areincorporated herein by reference in their entirety.

BACKGROUND

Obstructive sleep apnea (OSA) is a serious medical conditioncharacterized by complete or partial blockage of the upper airway duringsleep. The obstruction may be caused by relaxation of soft tissues andmuscles in or around the throat (e.g., the soft palate, back of thetongue, tonsils, uvula, and pharynx) during sleep. OSA episodes mayoccur multiple times per night, thus disrupting the patient's sleepcycle. Suffers of chronic OSA may experience sleep deprivation,excessive daytime sleepiness, chronic fatigue, headaches, snoring, andhypoxia.

The use of mandibular advancement devices (also referred to asmandibular splints or mandibular advancement splints) has been proposedto treat OSA. A mandibular advancement device is an oral appliance wornin the mouth over the teeth of the upper and/or lower jaws. The devicetreats sleep apnea by advancing the lower jaw in an anterior directionrelative to the upper jaw. This advancement tightens the tissues of theupper airway, thus inhibiting airway obstruction during sleep.

In some instances, however, existing mandibular advancement devices fortreating OSA may produce undesirable side effects, such as toothrepositioning, jaw discomfort, and muscle strain. Additionally, existingapproaches for designing and fabricating mandibular advancement devicesmay not account for or afford sufficient control over the forces appliedto the patient's teeth, which may limit the degree to which suchtreatments can be customized for the particular patient.

SUMMARY

Improved systems, methods, and devices for treating sleep apnea areprovided herein. An intraoral appliance for treating sleep apnea in apatient can be worn on a jaw of the patient and interact with theopposing jaw such that the lower jaw is displaced anteriorly relative tothe upper jaw in order to treat the sleep apnea with reducedunintentional tooth movement. The intraoral appliance may comprise aplurality of tooth receiving cavities and can be configured in one ormore of many ways to reduce unintentional tooth repositioning related tolower jaw displacement, such as with one or more of a thickness, astiffness, an interior shape, a position, or an orientation of a toothreceiving cavity. The appliance may comprise a shell having a pluralityof cavities shaped to receive teeth of the patient's jaw, and theplurality of cavities can be shaped to reduce and/or inhibitunintentional repositioning of one or more received teeth related to theanterior displacement of the lower jaw. The appliance can reduceunintentional repositioning with one or more of a modified forcedistribution on teeth, increasing anchorage of teeth, or constrainingmovements of teeth. The intraoral appliances having cavity geometriesshaped to provide an improved distribution of the forces applied to thepatient's teeth during mandibular advancement as described herein canalso be beneficial for development of patient-specific treatments thatbalance treatment effectiveness with patient comfort. Advantageously,the appliances described herein can also incorporate cavity geometriesshaped to reposition teeth in accordance with a prescribed orthodontictreatment plan, thereby allowing for the combined application oforthodontic and mandibular advancement therapies for treating sleepapnea.

Accordingly, in one aspect, an intraoral appliance for treating sleepapnea in a patient comprises an appliance shell comprising a pluralityof cavities shaped to receive teeth of a jaw of the patient, wherein theappliance shell comprises an advancement structure arranged to interactwith an opposing jaw of the patient so as to displace the lower jawanteriorly relative to the upper jaw, and wherein the plurality ofcavities comprises cavity geometries shaped to reduce repositioning ofone or more received teeth elicited by displacement of the lower jawanteriorly relative to the upper jaw.

In another aspect, an intraoral appliance for treating sleep apnea in apatient comprises an appliance shell shaped to receive teeth of a jaw ofthe patient, wherein the appliance shell comprises an advancementstructure arranged to interact with an opposing jaw of the patient so asto displace the lower jaw anteriorly relative to the upper jaw, andwherein the intraoral appliance applies an amount of anterior-posteriorforce to the patient's teeth that is no greater than a predeterminedthreshold force value.

Other objects and features of the present invention will become apparentby a review of the specification, claims, and appended figures.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A illustrates a patient's upper and lower jaws in a habitualocclusal position, in accordance with embodiments;

FIG. 1B illustrates a patient's upper and lower jaws in a“mandible-advanced” occlusal position, in accordance with embodiments;

FIG. 2 illustrates an intraoral appliance for treating sleep apnea bymandibular advancement, in accordance with embodiments;

FIG. 3A illustrates an intraoral appliance for treating sleep apnea bymandibular advancement, in accordance with embodiments;

FIG. 3B illustrates an anterior force produced by the intraoralappliance of FIG. 3A;

FIG. 4A illustrates exemplary tooth surfaces exposed to forcesassociated with mandibular advancement, in accordance with embodiments;

FIG. 4B illustrates a non-uniform force distribution applied on teethduring mandibular advancement;

FIG. 5 illustrates repositioning of anterior teeth elicited bymandibular advancement forces, in accordance with embodiments;

FIGS. 6A and 6B illustrate controlling anterior-posterior forcedistribution to reduce tooth repositioning elicited by mandibularadvancement, in accordance with embodiments;

FIG. 7 illustrates improving anchorage to reduce tooth repositioningelicited by mandibular advancement, in accordance with embodiments;

FIG. 8 illustrates a displacement-based approach for determining anamount of mandibular advancement, in accordance with embodiments;

FIG. 9 illustrates a force and displacement-based approach fordetermining an amount of mandibular advancement, in accordance withembodiments;

FIG. 10 illustrates a force-based approach for determining an amount ofcompensation for a mandibular advancement appliance, in accordance withembodiments;

FIG. 11 illustrates a method for producing an intraoral appliance fortreating sleep apnea in a patient, in accordance with embodiments;

FIG. 12 illustrates optimizing the position of an advancement structure,in accordance with embodiments;

FIGS. 13A through 13D illustrate optimizing the geometry of anadvancement structure, in accordance with embodiments;

FIG. 14 illustrates loss of mandibular advancement due to disengagementof advancement structures, in accordance with embodiments;

FIGS. 15A through 15C illustrates a magnetic coupling for advancementstructures, in accordance with embodiments;

FIG. 16A illustrates an alternative magnetic coupling for advancementstructures, in accordance with embodiments;

FIG. 16B illustrates a magnetic coupling with self-centeringcapabilities, in accordance with embodiments;

FIG. 16C illustrates adjustments to the geometry of a magnetic coupling,in accordance with embodiments;

FIG. 17A illustrates a mechanical coupling for advancement structurescomprising a cup and ball mechanism, in accordance with embodiments;

FIG. 17B illustrates a mechanical coupling for advancement structurescomprising textured surfaces, in accordance with embodiments;

FIG. 17C illustrates elastic tethers for coupling advancementstructures, in accordance with embodiments;

FIG. 18 illustrates a protocol for obtaining jaw kinematic data andoptimizing patient treatment, in accordance with embodiments;

FIG. 19A illustrates a tooth repositioning appliance, in accordance withembodiments;

FIG. 19B illustrates a tooth repositioning system, in accordance withembodiments;

FIG. 20 illustrates a method of orthodontic treatment using a pluralityof appliances, in accordance with embodiments;

FIG. 21 illustrates a method for digitally planning an orthodontictreatment, in accordance with embodiments;

FIG. 22 is a simplified block diagram of a data processing system, inaccordance with embodiments;

FIGS. 23A through 23C illustrate optimizing occlusal force distributionon the teeth, in accordance with embodiments;

FIGS. 24A through 24C illustrate occlusal views of symmetric andasymmetric jaw advancement, in accordance with embodiments; and

FIGS. 25A and 25B illustrate appliance design to accommodate a patient'sjaw asymmetry, in accordance with embodiments.

DETAILED DESCRIPTION

The present disclosure provides systems, methods, and devices fortreating sleep apnea (e.g., obstructive sleep apnea (OSA)) in a patientby displacing the lower jaw (mandible) of the patient anteriorlyrelative to the upper jaw (maxilla), also known as “mandibularadvancement.” The approaches described herein can be used to produceintraoral appliances for treating sleep apnea via mandibular advancementthat exhibit improved control over the forces that are transmitted tothe patient's teeth. In some embodiments, an appliance is designed toreduce or inhibit repositioning of teeth associated with mandibularadvancement, e.g., by redistributing forces elicited by the mandibularadvancement away from teeth that are more susceptible to repositioning(e.g., anterior teeth such as incisors and canines) and onto teeth thatare less susceptible to repositioning (e.g., posterior teeth such asmolars and premolars). In some embodiments, the appliance is configuredsuch that the anterior-posterior force exerted on the teeth by theappliance during advancement does not exceed a predetermined amount offorce, e.g., an amount that would cause tooth repositioning and/orpatient discomfort. Advantageously, the force-based design approachespresented herein can be used to achieve effective, patient-specifictreatment of sleep apnea while eliciting minimal or no undesirable sideeffects.

Thus, in one aspect, an intraoral appliance for treating sleep apnea ina patient comprises an appliance shell comprising a plurality ofcavities shaped to receive teeth of a jaw of the patient. The applianceshell can comprise an advancement structure arranged to interact with anopposing jaw of the patient so as to displace the lower jaw anteriorlyrelative to the upper jaw. The plurality of cavities can comprise cavitygeometries shaped to reduce repositioning of one or more received teethelicited by displacement of the lower jaw anteriorly relative to theupper jaw.

In another aspect, a method for producing an intraoral appliance fortreating sleep apnea in a patient comprises determining, with aid of oneor more processors, a geometry of an appliance shell comprising aplurality of cavities shaped to receive teeth of a jaw of the patient.The appliance shell can comprise an advancement structure arranged tointeract with an opposing jaw of the patient so as displace the lowerjaw anteriorly relative to the upper jaw. The plurality of cavities cancomprise cavity geometries shaped to reduce repositioning of one or morereceived teeth elicited by displacement of the lower jaw anteriorlyrelative to the upper jaw.

The cavity geometries can be designed in various ways. In someembodiments, the cavity geometries are shaped to apply a non-uniformforce distribution on the one or more received teeth. The non-uniformforce distribution can comprise an amount of force applied to one ormore posterior teeth that is greater than an amount of force applied toone or more anterior teeth. The plurality of cavities can comprise oneor more posterior cavities shaped to receive the one or more posteriorteeth, and the one or more posterior cavities can comprise a positiondifferent from a position of the one or more posterior teeth. The cavitygeometries can comprise a gap between an inner cavity wall and a surfaceof the one or more anterior teeth.

In some embodiments, the cavity geometries are shaped to increaseanchorage of at least one tooth of the one or more received teeth. Forexample, the cavity geometries can increase the anchorage of the atleast one tooth by constraining a tipping movement of the at least onetooth. As another example, the cavity geometries can increase theanchorage of the at least one tooth by applying a moment to the at leastone tooth in a direction opposing a force applied to the at least onetooth by the displacement. Optionally, the plurality of cavities cancomprise at least one cavity shaped to receive the at least one tooth,and the at least one cavity can comprise an orientation different froman orientation of the at least one tooth.

Some embodiments of the intraoral appliances presented herein can beconfigured to reposition one or more teeth as part of an orthodontictreatment regimen. In some embodiments, for example, the cavitygeometries are shaped to reposition one or more received teeth from aninitial tooth arrangement towards a target tooth arrangement accordingto an orthodontic treatment plan. The orthodontic treatment plan cancomprise repositioning one or more posterior teeth in order to increasean amount of space for the patient's tongue.

In some embodiments, the approaches described herein prevent unwantedmovements of anterior teeth caused by mandibular advancement treatment.For example, the plurality of cavities can be shaped to receive at leastone anterior tooth, and the cavity geometries can be shaped to reducerepositioning of the at least one anterior tooth elicited by thedisplacement. In some embodiments, the at least one anterior toothcomprises an anterior tooth of the lower jaw and the cavity geometriesare shaped to reduce anterior flaring of the anterior tooth of the lowerjaw elicited by the displacement. In some embodiments, the at least oneanterior tooth comprises an anterior tooth of the upper jaw and thecavity geometries are shaped to reduce retraction of the anterior toothof the upper jaw elicited by the displacement.

Certain embodiments presented herein provide intraoral appliancesdesigned to be worn on the upper and lower jaws. For example, theappliances described herein can further comprise a second applianceshell comprising a second plurality of cavities shaped to receive teethof the opposing jaw. The second plurality of cavities can comprisecavity geometries shaped to reduce repositioning of one or more receivedteeth elicited by the displacement. The advancement structure caninteract with the opposing jaw via engagement with a second advancementstructure of the second appliance shell.

In some embodiments, the advancement structure comprises a firstprotrusion extending from the appliance shell and having a firstengagement surface, and the second advancement structure comprises asecond protrusion extending from the second appliance shell and having asecond engagement surface configured to engage the first engagementsurface. The first protrusion can be shaped to mate with the secondprotrusion. An inclination angle of the first and second engagementsurfaces can be determined based on one or more of anatomy of thepatient's jaw, kinematic data of the patient's jaw, or a targeteddistance for the displacement.

In some embodiments, the advancement structure comprises a firstcoupling element and the second advancement structure comprises a secondcoupling element, the first and second coupling elements configured tointeract with each other so as to reversibly bias the advancementstructure and second advancement structure toward predetermined relativepositions. The first and second coupling elements can comprise magneticelements, elastic tethers, mating features, or combinations thereof, forinstance.

In another aspect, an intraoral appliance for treating sleep apnea in apatient comprises an upper shell comprising a first advancementstructure and a first plurality of cavities shaped to receive teeth ofthe patient's upper jaw, and a lower shell comprising a secondadvancement structure and a second plurality of cavities shaped toreceive teeth of the patient's lower jaw. The first and secondadvancement structures can be arranged to engage each other so as toproduce displacement of the lower jaw anteriorly relative to the upperjaw when the appliance is worn by the patient in order to treat thesleep apnea. At least one of the first plurality of cavities or thesecond plurality of cavities can comprise cavity geometries shaped toreduce repositioning of one or more received teeth elicited by thedisplacement.

In another aspect, a method for producing an intraoral appliance fortreating sleep apnea in a patient comprises determining, with aid of oneor more processors, a geometry of an upper shell comprising a firstadvancement structure and a first plurality of cavities shaped toreceive teeth of the patient's upper jaw. The method can comprisedetermining, with aid of one or more processors, a geometry of a lowershell comprising a second advancement structure and a second pluralityof cavities shaped to receive teeth of the patient's lower jaw. Thefirst and second advancement structures can be arranged to engage eachother so as to produce displacement of the lower jaw anteriorly relativeto the upper jaw when the appliance is worn by the patient in order totreat the sleep apnea. At least one of the first plurality of cavitiesor the second plurality of cavities can comprise cavity geometriesshaped to reduce repositioning of one or more received teeth elicited bythe displacement.

In another aspect, an intraoral appliance for treating sleep apnea in apatient by displacing a lower jaw of the patient anteriorly relative toan upper jaw of the patient comprises an appliance shell shaped toreceive teeth of a jaw of the patient. The appliance shell can comprisean advancement structure arranged to interact with an opposing jaw ofthe patient so as to displace the lower jaw anteriorly relative to theupper jaw. The intraoral appliance can apply an amount ofanterior-posterior force to the patient's teeth that is no greater thana predetermined threshold force value.

In another aspect, a method for producing an intraoral appliance fortreating sleep apnea in a patient comprises determining, with aid of oneor more processors, a threshold force value for an amount ofanterior-posterior force that would be applied to the patient's teeth inorder to displace the patient's lower jaw anteriorly relative to thepatient's upper jaw. The method can comprise determining, with aid ofthe one or more processors, a geometry for an intraoral applianceconfigured to displace the lower jaw anteriorly relative to the upperjaw when worn by the patient in order to treat the sleep apnea, whereinthe intraoral appliance applies an amount of anterior-posterior force tothe patient's teeth that is no greater than the threshold force value.

In another aspect, a system for producing an intraoral appliance fortreating sleep apnea in a patient comprises one or more processors andmemory comprising instructions executable by the one or more processorsto cause the system to at least determine a threshold force value for anamount of anterior-posterior force that would be applied to thepatient's teeth in order to displace the patient's lower jaw anteriorlyrelative to the patient's upper jaw. The instructions can cause thesystem to determine a geometry for an intraoral appliance configured todisplace the lower jaw anteriorly relative to the upper jaw when worn bythe patient in order to treat the sleep apnea, wherein the intraoralappliance applies an amount of anterior-posterior force to the patient'steeth that is no greater than the threshold force value.

The threshold force value can be varied as desired. In some embodiments,the threshold force value is about 20 N. The threshold force value maybe no greater than an amount of anterior-posterior force associated withpatient discomfort, tooth repositioning, and/or temporamandibular jointdysfunction. For example, the threshold force value can be less than anamount of anterior-posterior force that is uncomfortable for theparticular patient, thus reducing or eliminating pain experienced by thepatient during treatment. As another example, the threshold force valuecan be less than an amount of anterior-posterior force that would injurethe jaw muscles and/or TMJ of the patient, in order to reduce treatmentrisk. In some embodiments, the threshold force value can be less than anamount of anterior-posterior force that would cause unintended movementsof the jaws and/or teeth, in order to reduce the incidence of adverseside effects.

In some embodiments, the intraoral appliance comprises an upper shellcomprising a first advancement structure and a first plurality ofcavities shaped to receive teeth of the upper jaw, and a lower shellcomprising a second advancement structure and a second plurality ofcavities shaped to receive teeth of the lower jaw. The first and secondadvancement structures can be arranged to engage each other so as todisplace the lower jaw anteriorly relative to the upper jaw. At leastone of the first plurality of cavities or the second plurality ofcavities can comprise cavity geometries shaped to reduce repositioningof one or more received teeth elicited by anterior displacement of thelower jaw relative to the upper jaw.

In some embodiments, the method further comprises receiving, with aid ofthe one or more processors, measurement data indicative of apatient-specific relationship between anterior displacement of the lowerjaw relative to the upper jaw and anterior-posterior force applied tothe patient's teeth. The method can further comprise determining, withaid of one or more processors, a threshold displacement value for anamount of anterior displacement of the lower jaw relative to the upperjaw corresponding to the threshold force value, wherein the intraoralappliance is configured to displace the lower jaw relative to the upperjaw by an amount no greater than the threshold displacement value.

In some embodiments, the instructions further cause the system toreceive measurement data indicative of a patient-specific relationshipbetween anterior displacement of the lower jaw relative to the upper jawand anterior-posterior force applied to the patient's teeth. Theinstructions can further cause the system to determine a thresholddisplacement value for an amount of anterior displacement of the lowerjaw relative to the upper jaw corresponding to the threshold forcevalue, wherein the intraoral appliance is configured to displace thelower jaw relative to the upper jaw by an amount no greater than thethreshold displacement value.

In another aspect, a method comprises providing an appliance inaccordance with any of the embodiments presented herein.

In another aspect, a mandible advancement appliance comprises an upperjaw retainer having an upper mandibular advancement feature and a lowerjaw retainer having a lower mandibular advancement feature. The upperand lower mandibular advancement features can be configured to engageeach other to advance the lower jaw retainer in an anterior directionrelative to the upper jaw retainer when the retainers are closedtogether as they would be when worn by a patient. Optionally, the upperand lower mandibular advancement features can engage each other along anengagement plane, and the angle of the engagement plane can be designedto resist the opening of the patient's jaws. An upper coupling elementon the upper mandibular advancement feature and a lower coupling elementon the lower mandibular advancement features can be configured toreversibly bias or “urge” the upper and lower mandibular advancementfeatures toward preselected relative positions. The preselected relativeposition can include a specific degree or distance of mandibularadvancement and may further include a desired degree of mouth opening orthe like. Specific coupling elements can include magnets as well asreversible locking mechanisms as described in more detail below.

The upper and lower coupling elements may take any one of a variety offorms. In some embodiments, the upper and lower coupling elementscomprise an upper magnetic element on the upper mandibular advancementfeature and a lower magnetic element on the lower mandibular advancementfeature. The upper and lower magnetic elements can be disposed on upperand lower engagement surfaces which are located on the upper and lowermandibular advancement features, respectively. Alternatively, the upperand lower coupling elements can comprise one or more elastic tetherswhich are connected between the upper and lower mandibular advancementfeatures and oriented to bias the features toward the pre-selectedrelative positions. As a further alternative, the upper and lowercoupling elements may comprise mechanical latch members which hold themandibular advancement features at the pre-selected relative positions.For example, the mechanical latch members may comprise textured surfacesor may comprise a cup and ball.

In another aspect, a mandibular advancement system comprises a primaryshell or retainer configured to removably anchor to one of a patient'supper and lower jaw and a plurality of secondary shells or retainersconfigured to removably anchor to the other of the patient's upper andlower jaw. The primary retainer has a mandibular advancement feature andeach of the secondary retainers has a mandibular advancement feature. Atleast some of the mandibular advancement features on the secondaryretainers can be positioned differently on the secondary retainers thanare others of the mandibular advancement features on others of thesecondary retainers so that a user can select a particular secondaryretainer to achieve a particular degree of mandibular advancement. Suchmandibular advancement systems may be used by a patient by placing theprimary retainer over one jaw and a first secondary retainer over thesecond jaw at a first time to achieve a first degree of mandibularadvancement. At a second time, the primary retainer may again be placedover the one jaw and a second secondary retainer over the second jaw. Byproperly selecting the second retainer, a different degree of mandibularadvancement and/or mouth opening can be achieved.

In another aspect, a method for designing a mandibular advancementapplication for an individual patient comprises obtaining datarepresenting the patient's tooth position and natural upper and lowerjaw positions and receiving target mandibular advancement information.Design information for upper and lower jaw retainers or shells can begenerated for the patient, where the design information includes atleast the relative positions of upper and lower mandibular advancementfeatures on the upper and lower retainers, respectively, and toothengagement plans for the upper and lower retainers which favorablydistribute orthodontic load minimize orthodontic load on the individualpatient's teeth during use of the mandibular advancement appliance. Thedesign information may be used to fabricate a mandibular advancementdevice.

It shall be appreciated that any of the embodiments herein describedwith reference to an upper jaw of the patient can also be applied to alower jaw of the patient, and vice-versa. Additionally, where the upperand lower jaws are referenced in relation to each other, it iscontemplated that the term “opposing” or “corresponding” can beinterchangeably applied to either jaw, such any reference herein to an“upper jaw” and “opposing lower jaw” may be considered to beinterchangeable with a “lower jaw” and “opposing upper jaw.”

Any of the systems and methods of treatment of the present disclosurecan be used with daytime retainers to avoid tooth repositioning, but itmay be preferable to design the mandibular advancement appliance toavoid inducing orthodontic tooth movement in the first place.

As used herein the terms “torque” and “moment” are treated synonymously.

As used herein the term “and/or” is used as a functional word toindicate that two words or expressions are to be taken together orindividually. For example, A and/or B encompasses A alone, B alone, andA and B together.

Turning now to the drawings, in which like numbers designate likeelements in the various figures, FIG. 1A illustrates an upper jaw 100and a lower jaw 102 of a patient in a habitual occlusal position, inaccordance with embodiments. The habitual occlusal position cancorrespond to the normally closed position of the upper and lower jaws100, 102. Patients suffering from sleep apnea may experience restrictedairflow due to blockage of the upper airway if the upper and lower jaws100, 102 remain in their habitual occlusal relationship during sleep dueto relaxation of soft tissues in or around the upper airway.

FIG. 1B illustrates the upper jaw 100 and lower jaw 102 in a“mandible-advanced” occlusal position, in accordance with embodiments.In the advanced position, the lower jaw 102 has been displaced from itshabitual position along an anterior direction (indicated by arrow 104)such that the lower jaw 102 is now positioned anteriorly relative to theupper jaw 100. The advanced position of the lower jaw 102 can be used totighten the soft tissues of the upper airway, thus maintainingunobstructed airflow during sleep.

In some embodiments, an intraoral appliance is worn by the patient inthe order to displace the lower jaw anteriorly relative to the upper jawto treat sleep apnea. The intraoral appliance can be a patient-removableappliance (e.g., the patient can place and remove the appliance withoutaid from a practitioner) that is inserted into the patient's mouth priorto sleep so as to maintain the lower jaw in an advanced position duringsleep, and is removed from the patient's mouth while the patient isawake to allow for normal activity. In alternative embodiments, theintraoral appliance can include one or more components that are notpatient-removable (e.g., attachments or brackets affixed to one or moreteeth, anchoring devices positioned in the tissue of the intraoralcavity such as bone).

In some embodiments, the intraoral appliance includes at least oneappliance shell having a plurality of cavities shaped to receive teethof a single jaw of the patient (e.g., the upper jaw or the lower jaw).An appliance shell can be a retainer having tooth-receiving cavitiesshaped to maintain the patient's teeth in a current tooth arrangement.In other embodiments, an appliance shell can be a device for toothrepositioning in which the cavities are shaped to reposition one or morereceived teeth from an initial arrangement to a target tootharrangement, as described further herein. Optionally, an appliance shellcan be configured to maintain some teeth in a current arrangement whilerepositioning others to a different arrangement, as discussed herein.The appliance can be fabricated with one or more of many materials suchas metal, glass, reinforced fibers, carbon fiber, composites, reinforcedcomposites, aluminum, biological materials, or combinations thereof. Theappliance can be manufactured in many ways, such as with thermoformingor direct fabrication as described herein. Alternatively or incombination, the appliance can be fabricated with machining, such as anappliance fabricated from a block of material with computer numericcontrol (CNC) machining. Alternatively or in combination, additivemanufacturing processes such as stereolithography or 3-D printing can beused to fabricate the appliances described herein.

A shell for an intraoral appliance can include at least one advancementstructure arranged to interact with an opposing jaw of the patient, suchas by directly contacting the opposing jaw, or indirectly by engaginganother appliance positioned on the opposing jaw (e.g., a second shell,an attachment, an anchoring device, etc.). The interaction of theadvancement structure with the opposing jaw can produce forces thatdisplace the lower jaw anteriorly relative to the upper jaw. Forexample, the intraoral appliance can include an upper shell and a lowershell. Each of the upper shell and lower shell can have a set of teethreceiving cavities shaped to accommodate teeth of the upper jaw andlower jaw, respectively. The upper shell can have an advancementstructure that engages a corresponding advancement structure of thelower shell when the appliance is worn by the patient so as to bring thetwo shells towards each other (e.g., the patient's jaws are closed). Theengagement of the two advancement structures can displace the lowershell anteriorly relative to the upper shell, thereby advancing thelower jaw. Optionally, the advancement structures can constrain themovements of the upper and lower jaws with respect to up to six degreesof freedom, so as to prevent the jaws from returning to the habitualposition once the advancement structures are engaged.

The design of the advancement structures described herein can be variedas desired to produce the forces for mandibular advancement. Forexample, an advancement structure can include protruding members,recesses, tension members (e.g., elastics, tension springs), compressionmembers (e.g., compression springs) or combinations thereof. Anadvancement structure can be located on any portion of the appliance,such as on a buccal surface, lingual surface, occlusal surface, orcombinations thereof. An intraoral appliance can include any number andcombination of advancement structures, such as a single structure (e.g.,a single structure connecting upper and lower shells), a pair ofstructures (e.g., paired upper and lower structures, two structureslocated on opposite sides of the appliance), three structures, fourstructures (e.g., two sets of paired upper and lower structures locatedon opposite sides of the appliance), or more.

FIG. 2 illustrates an intraoral appliance 200 for treating sleep apneaby mandibular advancement, in accordance with embodiments. The appliance200 includes an upper appliance shell 202 having a plurality of cavitiesfor receiving teeth of the upper jaw (e.g., an upper or maxillaryretainer) and a lower appliance shell 204 having a plurality of cavitiesfor receiving teeth of the lower jaw (e.g., a lower or mandibularretainer). In some embodiments, the upper and lower shells 202, 204 eachreceive some or all of the anterior teeth (e.g., incisors, canines) andsome or all of the posterior teeth (e.g., molars, premolars). The uppershell 202 includes an upper advancement structure 206 (e.g., a maxillaryor upper mandibular advancement feature) and the lower shell 204includes a lower advancement structure 208 (e.g., a mandibular or lowermandibular advancement feature). The upper advancement structure 206engages the lower advancement structure 208 to displace the lower shell204 anteriorly relative to the upper shell 202, thereby advancing themandible when the appliance 200 is worn by the patient. Since the upperadvancement structure 206 is positioned posteriorly relative to thelower advancement structure 208, engagement of the upper and loweradvancement structures 206, 208 produces an anterior force that pushesthe mandible in an anterior direction. Optionally, the upper and loweradvancement structures 206, 208 can be arranged to prevent posteriormovement of the mandible while being unrestrictive of anterior, opening,or closing movements of the mandible.

In the appliance 200, the upper advancement structure 206 is depicted asa protrusion extending downwards towards the lower jaw, and the loweradvancement structure 208 is depicted as a protrusion extending upwardstowards the upper jaw, such that the two protrusions contact and engageeach other along an engagement region 210 when the upper and lowershells 202, 204 are brought together. For instance, the engagementregion 210 can encompass a surface of the upper protrusion (e.g., ananterior surface) that engages a corresponding engagement surface of thelower protrusion (e.g., a posterior surface). Optionally, the upper andlower protrusions can have complementary shapes that mate with eachother to improve the stability of engagement.

In the embodiment of FIG. 2, the upper and lower advancement structures206, 208 are depicted as being located on the buccal surfaces of theupper and lower shells 202, 204, respectively. In alternativeembodiments, the advancement structures 206, 208 can be positioned onother surfaces of the shells 202, 204, such as on the lingual surfacesor occlusal surfaces. Additionally, although FIG. 2 depicts a singlepair of advancement structures 206, 208, one of ordinary skill in theart would appreciate that the appliance 200 can be modified as desiredto include multiple pairs of advancement structures located at differentportions of the appliance 200 (e.g., a first pair located on the leftside of the appliance 200 and a second pair located on the right side ofthe appliance 200).

FIG. 3A illustrates an intraoral appliance 300 for treating sleep apneaby mandibular advancement, in accordance with embodiments. Similar tothe appliance 200, the appliance 300 includes an upper shell 302 and alower shell 304 having teeth-receiving cavities for the upper and lowerjaws of the patient, respectively. The advancement structure of theappliance 300 is a connecting structure 306 that is coupled to the uppershell 302 at an upper anchor point 308 and to the lower shell 304 at alower anchor point 310, thus connecting the upper and lower shells 302,304 to each other.

FIG. 3B illustrates an anterior force produced by the intraoralappliance 300 of FIG. 3A. In the embodiment of FIGS. 3A and 3B, theconnecting structure 306 is a compression member (e.g., a compressionspring) that exerts an outward axial force 312. Since the upper anchorpoint 308 is positioned posteriorly relative to the lower anchor point310, the force 312 includes an anterior force component 314(F_(anterior)) that pushes the mandible in an anterior direction. Inalternative embodiments, the connecting structure 306 can be a tensionmember (e.g., an elastic, tension spring) and the upper anchor point 308can be positioned anteriorly relative to the lower anchor point 310,such that the inward axial force produced by the tension member wouldhave an anterior force component to pull the mandible in an anteriordirection.

FIGS. 4A and 4B illustrate forces applied to teeth by an intraoralappliance during mandibular advancement, in accordance with embodiments.FIG. 4A illustrates exemplary tooth surfaces exposed to a force 400associated with mandibular advancement. An intraoral appliance can applya net anterior (protrusive) force 400 on the patient's mandible or lowerarch 402 in order to advance the mandible. The appliance can also applya net posterior (retrusive) force on the patient's maxilla or lower arch(not shown). Teeth having more exposed surfaces orthogonal to the forcedirection may bear more of the applied force than teeth having lessexposed orthogonal surfaces. For example, in the lower arch 402, theexposed orthogonal surfaces include the lingual surfaces of anteriorteeth 404 (e.g., the lingual surfaces of the incisors) and the distalsurfaces of posterior teeth 406 (e.g., the distal surfaces of theterminal molars). In the upper arch (not shown), the exposed orthogonalsurfaces include the buccal surfaces of the anterior teeth (e.g., thebuccal surfaces of the incisors).

FIG. 4B illustrates a non-uniform force distribution 450 applied onteeth during mandibular advancement. In the lower arch, since thelingual surface of the anterior teeth is relatively large compared tothe distal surface area of the posterior teeth, the majority of theforce is applied to the anterior teeth. An anterior tooth 452 (e.g.,incisor) can be more susceptible to tipping, since the force applied tothe tooth has a large moment arm 454 with respect to the center ofresistance 456, creating a large tipping moment. In contrast, aposterior tooth 458 (e.g., molar) can be less susceptible to tipping,since the applied force has a smaller moment arm 460 with respect to thecenter of resistance 462. The remaining force can be distributed amongthe exposed surfaces of other teeth, e.g., the interproximal, buccal,lingual, and/or occlusal surfaces. The amount of force applied to theseteeth can depend on the extent to which the appliance contacts andengages the teeth, as described further herein.

FIG. 5 illustrates repositioning of anterior teeth elicited bymandibular advancement forces, in accordance with embodiments. Asdescribed herein, mandibular advancement using intraoral appliances canresult in application of forces to the anterior teeth, such as anteriorforces to anterior teeth of the lower jaw and posterior forces toanterior teeth of the upper jaw. For example, an anterior force appliedto a lower anterior tooth 500 can cause tipping movements such as labialinclination 502, which can result in flaring or protrusion of the tooth500. A posterior force applied to an upper anterior tooth 504 can causetipping movements such as lingual inclination 506, which can result inretraction of the tooth 504. This repositioning of the anterior teethcan cause alterations in the patient's bite characteristics, such as adecrease in the amount of overbite 508 and/or a decrease in the amountof overjet 510.

In some embodiments, tooth repositioning is an unintentional andundesirable side effect of mandibular advancement using intraoralappliances. As discussed herein, the anterior-posterior forces that areapplied to the patient's jaws to advance the mandible can bedisproportionately distributed onto the anterior teeth, which can bemore susceptible to repositioning (e.g., anterior flaring and/orretraction). Accordingly, the intraoral appliances described herein canbe designed to eliminate unintentional repositioning of teeth caused byanterior displacement of the mandible. Various approaches can be used toproduce such appliances. In some embodiments, the appliance includes ashell having a plurality of teeth-receiving cavities with geometriesshaped to reduce or eliminate repositioning of the received teeth of apatient's jaw. For example, the cavities can receive and encapsulate oneor more lower anterior teeth in order to reduce or prevent anteriorflaring of the lower anterior teeth. As another example, the cavitiescan receive and encapsulate one or more upper anterior teeth in order toreduce or prevent retraction of the upper anterior teeth. In someembodiments, the appliance can include a pair of interacting applianceshells that receive teeth of the upper and lower jaws, respectively, andinclude respective cavity geometries designed to reduce or preventunwanted repositioning of both upper and lower teeth.

In some embodiments, the cavity geometries of an appliance are shaped tomatch the current arrangement of one or more teeth in order to constrainthe teeth to the current arrangement. The cavity geometries can beshaped to maintain all of the teeth in the current arrangement, suchthat no repositioning is allowed to occur. Alternatively, the cavitygeometries can be shaped to maintain some teeth in the currentarrangement while allowing for repositioning of other teeth (e.g., inaccordance with an orthodontic treatment plan) as described furtherherein. In such embodiments, the cavity geometries can correspond to atooth arrangement different from the current tooth arrangement of thepatient.

Optionally, the appliance can be manufactured from one or more materialsthat resist deformation when under load in order to constrain the teethand prevent repositioning away from the current tooth arrangement. Thematerial(s) can be selected to provide a desired amount of stiffnessand/or thickness in order to reduce appliance distortion when worn. Forexample, the appliance can have an elastic modulus of about 0.5 GPa, 1GPa, 1.5 GPa, 2 GPa, 2.5 GPa, 2.5 GPa, 3 GPa, or 3.5 GPa. In someembodiments, the appliance has an elastic modulus within a range fromabout 1 GPa to about 3 GPa. Alternatively or in addition, the appliancecan have a thickness of about 5 mils, 10 mils, 15 mils, 20 mils, 25mils, 30 mils, 35 mils, 40 mils, 45 mils, 50 mils, 55 mils, 60 mils, 65mils, or 70 mils. In some embodiments, the appliance has a thicknesswithin a range from about 10 mils to about 60 mils. In embodiments wherethe intraoral appliance is worn only during sleep, there may be moreflexibility in the choice of materials compared to other types ofintraoral appliances, since factors such as aesthetics (e.g.,transparency) may be of less importance. Optionally, appliances that aredesigned to permit some planned repositioning can have heterogeneousproperties, e.g., increased stiffness and/or thickness near teeth thatare constrained and reduced stiffness and/or thickness near teeth to berepositioned.

In some embodiments, the intraoral appliances described herein can bedesigned to apply one or more forces and/or moments to the teeth thatreduce or eliminate undesirable tooth repositioning elicited bymandibular advancement. For example, an appliance can be configured tocontrol the distribution of forces applied to the teeth. The amount ofmandibular advancement achieved by an appliance depends on the net force(F_(net)) applied to the mandible, the net force being the summation ofthe forces applied to each tooth. It can be seen that different forcedistributions can generate the same amount of net force on the jaw.Accordingly, by controlling the force distribution applied to the teethby the appliance, force loads on teeth susceptible to repositioning canbe reduced while achieving the same amount of mandibular advancement.

FIGS. 6A and 6B illustrate controlling anterior-posterior forcedistribution to reduce tooth repositioning elicited by mandibularadvancement, in accordance with embodiments. FIG. 6A illustrates theforces applied to individual teeth by different force distributions,while FIG. 6B illustrates the net force profile over the entire arch fordifferent distributions. As discussed herein, a “naive” forcedistribution 600 applied by an appliance that is not designed to reduceunwanted tooth repositioning can exhibit relatively large forces appliedto anterior teeth and relatively small forces applied to posteriorteeth. In some embodiments, an intraoral appliance designed to reducetooth repositioning can produce a uniform force distribution 602 inwhich each tooth receives an equal amount of force (see inner arrows inFIG. 6A). In other embodiments, an intraoral appliance designed toreduce tooth repositioning can apply a non-uniform or “preferential”force distribution 604 in which certain teeth receive a larger amount offorce than other teeth (see outer arrows in FIG. 6A). For example, anappliance shell worn on the lower jaw can exhibit a preferentialdistribution 604 with larger anterior forces on the posterior teeth andsmaller anterior forces on the anterior teeth. Similarly, an applianceshell worn on the lower jaw can exhibit a preferential distribution (notshown) with larger posterior forces on the posterior teeth and smallerposterior forces on the anterior teeth. In the depicted embodiment, thenet force applied by each of the three distributions is equal, such thatthe same amount of mandibular advancement is produced.

Various criteria can be considered in order to determine which teethshould bear larger loads in a non-uniform force distribution. In someembodiments, the determination is performed based on the tooth'sresistance to movement, also known as the “anchorage value.” Posteriorteeth can be more resistant to movement due to their larger root surfacearea. Additionally, anterior/posterior (mesial/distal) tipping movementsof posterior teeth such as molars can be limited due to interference byneighboring teeth, while anterior teeth do not encounter such resistanceto buccal/lingual tipping. Accordingly, in some embodiments, it isdesirable to preferentially load the posterior teeth in order tominimize unwanted tooth movements.

Alternatively or in combination with the force distribution approachesdescribed herein, an intraoral appliance can be configured to apply oneor more forces and/or moments that increase the resistance of one ormore teeth to repositioning, referred to herein as “improvinganchorage.” Various methods can be used to improve anchorage of teeth.For example, the appliance can include cavity geometries shaped toimprove anchorage of certain teeth by reducing or inhibiting movement ofthe teeth along at least one direction of motion, e.g., with respect toup to six degrees of freedom in movement (up to three degrees of freedomin translation and up to three degrees of freedom in rotation) in orderto produce improved anchorage. In some embodiments, the anchorage valueof a tooth is inversely proportional to the pressure applied to theperiodontal ligament (PDL), and certain types of movements producelarger amounts of pressure on the PDL. For example, tipping movementscan produce larger loads on the PDL compared to translational movementswhich load the PDL more uniformly. Accordingly, the anchorage of thetooth can be improved by constraining the tooth to only certain types ofmovements (e.g., only translational movements) that produce lesspressure on the PDL. In some embodiments, this is achieved by applyingforces and/or moments to the teeth that oppose the movement to beconstrained. Optionally, one or more forces and/or moments can beapplied to counteract or oppose a force or moment that would elicit theconstrained movement. As another example, anchorage can be improved byconstraining multiple teeth to move together, which can increase theresistance to movement due to the increased shared root area.

FIG. 7 illustrates improving anchorage to reduce tooth repositioningelicited by mandibular advancement, in accordance with embodiments. Anet anterior force 700 is applied to a group of lower teeth 702 toproduce anterior displacement of the mandible. Each tooth has a certainamount of root surface area 704 adjacent to the PDL. In order todecrease the amount of pressure exerted on the PDL, the teeth 702 can beconstrained to inhibit tipping and permit only translational movements.For example, this can be achieved by designing the appliance to applyone or more moments 708 (e.g., mesial root torques) to the teeth 702 ina direction opposing the force load 700, thereby engaging the teeth 702while constraining them to a translational movement. The use of opposingmoments can additionally be used to compensate and/or counteractundesirable tooth movements, such as anterior flaring. In the embodimentof FIG. 7, each of the moments 708 is applied to an individual tooth.Alternatively or in combination, a single moment can be applied to agroup of multiple teeth.

Many different approaches can be used to design intraoral appliancesthat apply forces and/or moments to teeth to reduce undesirablerepositioning (e.g., by controlling the force distribution and/orimproving anchorage). In some embodiments, the appliances providedherein include a shell having a plurality of teeth-receiving cavitieswith geometries shaped to apply a specified system of forces and/ormoments, such as a desired force distribution. For example, the cavitygeometries can be shaped to exhibit differing amounts of engagement withthe received teeth in order to control the resultant forces, moments,and/or force distribution. Engagement can refer to the amount of contactbetween the inner wall of a tooth-receiving cavity and the exteriorsurface of the received tooth, for instance. The amount of force appliedto a tooth by the appliance can vary based on the extent to which theappliance engages the tooth, e.g., more force is transmitted to moreengaged teeth and less force is transmitted to less engaged teeth. Thus,cavities designed to apply relatively large amounts of force to thereceived teeth can have interior geometries that closely conform to thegeometries of the teeth to increase the surface area in contact with theteeth, thus allowing for greater force transmission. In contrast,cavities designed to apply relatively small amount of force or no forceto the received teeth can have geometries that differ from thegeometries of the received teeth in order to reduce the surface area incontact with the teeth. For instance, a gap or space can be formedbetween the inner cavity wall and one or more surfaces of the receivedteeth (e.g., a lingual surface of a lower anterior tooth, a buccalsurface of an upper anterior tooth) to reduce or prevent forcetransmission to the teeth. Accordingly, a desired force distribution(e.g., uniform or non-uniform) can be achieved by shaping the cavitygeometries to control the degree of engagement with each tooth.Referring again to the embodiments of FIGS. 6A and 6B, the preferentialforce distribution 604 can be achieved by increasing engagement of thecavities with the posterior teeth and reducing engagement of thecavities with the anterior teeth. Additionally, in some embodiments, itis beneficial to improve the engagement of the appliance with otherportions of the dentition, such as the interproximal regions of teeth,in order to distribute loads across more teeth.

As another example, the forces and/or moments produced by an appliancecan be controlled by adjusting the positions and/or orientations ofteeth-receiving cavities with respect to up to six degrees of freedom.Differences between the position and orientation of the cavity and theposition and orientation of the received tooth can produce forces and/ormoments on the tooth, due to elastic deformation of the appliance toaccommodate the tooth when the appliance is worn. For example, a cavitythat is translated relative to the position of the received tooth canapply a translational force on the tooth along the direction oftranslation. Similarly, a cavity that is rotated relative to theorientation of the received tooth can apply a moment on the tooth alongthe direction of rotation. Accordingly, a desired force distribution(e.g., uniform or non-uniform) can be achieved by adjusting thepositions and/or orientations of the tooth-receiving cavities relativeto the actual tooth arrangement to control the forces and/or momentsapplied to each tooth. Referring again to the embodiments of FIGS. 6Aand 6B, the preferential force distribution 604 can be achieved bypositioning the posterior teeth-receiving cavities in a positiondifferent from the actual positions of the posterior teeth. For example,the posterior cavities can be positioned in the appliance anteriorlyrelative to the actual positions of the posterior teeth. Upon placingthe appliance on the teeth, the shell would elastically deform and applyan anterior force on the posterior teeth. Similarly, the positionsand/or orientations of the tooth-receiving cavities can be adjustedrelative to the actual tooth arrangement to apply forces and/or momentsthat improve anchorage of one or more teeth. Referring again to theembodiment of FIG. 7, the cavity geometries can have an orientationdifferent from the actual orientation of the received teeth in orderproduce a moment that inhibits tipping.

In some embodiments, modifications to tooth morphology can be used toadjust the forces and/or moments that are applied to the teeth. Forexample, tooth morphology can be modified by affixing one or moreattachments to the surfaces of one or more teeth. Examples of suchattachments include buttons, protrusions, brackets, or clips, or anyother dental engagement device that is capable of interacting with theappliance to improve engagement, control the applied forces and/ormoments, constrain movement of the teeth relative to the appliance, orcombinations thereof. In some embodiments, the attachment ismanufactured from standard materials for long-term dental use, e.g.,materials for dental prostheses or restorations such as composites, soas to allow for long-term treatment without compromising aesthetics. Theappliance geometry (e.g., cavity geometries) can be shaped toaccommodate the attachment, e.g., via receptacles or apertures thatreceive the attachment, ridges or dimples that engage the attachment, orcombinations thereof. The geometry and placement of such attachments canbe designed in order to achieve the desired force and/or moment when theappliance engages the attachments, e.g., in accordance with a specifiedforce distribution and/or to improve anchorage.

In some embodiments, the approaches described herein can be used toproduce a plurality of intraoral appliances that are alternatingly wornby the patient in order to produce mandibular advancement while avoidingunintentional repositioning of teeth. Each appliance can produce adifferent force distribution on the teeth, such that the loading of theteeth is not constant across different appliances. For example, a firstappliance can have cavity geometries that apply a first forcedistribution to the patient's arch, and a second appliance can havecavity geometries that apply a second, different force distribution tothe patient's arch. By using different appliances that apply differentforces on the teeth, constant loading of the teeth can be avoided, whichcan reduce or inhibit unintentional tooth movement. Such appliances canbe applied to the patient's teeth in various ways. For example, thepatient can wear one appliance until unintentional repositioning isobserved, then switch to a different appliance in order to alter theforce distribution on the teeth. As another example, the patient canalternate between different appliances according to a predeterminedschedule (e.g., every other day) in order to vary the forces on theteeth in order to avoid constant loading.

Alternatively or in combination, a patient can be treated with a set ofappliances that are alternatingly worn during sleep and when the patientis awake in order to produce mandibular advancement while avoidingunintentional repositioning of teeth. For instance, a first appliancecan be worn during sleep in order to reduce sleep apnea and a secondappliance can be worn while the patient is awake in order to reverse,reduce, and/or eliminate any unintended movement of the teeth and/orjaws caused by the first appliance. In some embodiments, the secondappliance only includes anterior-posterior positioning structures toplace the patient's jaws back into the normal occlusion (e.g.,structures to retract the mandible relative to the maxilla) and does notinclude any activations to reposition teeth. In such embodiments, thesecond appliance would serve primarily as a retainer for maintaining thepatient's current tooth arrangement and bite alignment. Alternatively,the second appliance can include activations to reposition one or moreteeth (e.g., to correct malocclusion).

The intraoral appliances described herein can be customized for aparticular patient. In some embodiments, an appliance is configured toproduce a predetermined amount of mandibular advancement that iseffective for treating the patient's sleep apnea while reducing theincidence of undesirable side effects such as tooth repositioning,muscle strain, temporamandibular joint (TMJ) dysfunction, bitealterations, and jaw discomfort. For instance, the optimal amount ofanterior displacement to be effected by a mandibular advancementtreatment plan can be customized according to the patient's jaw anatomy,jaw kinematic data (e.g., jaw border movements, habitual opening amount,maximum opening amount), and/or degree of jaw discomfort experienced. Insome embodiments, the practitioner measures characteristics of thepatient's jaws in order to determine a suitable amount of mandibularadvancement to be applied.

FIG. 8 illustrates a displacement-based approach for determining anamount of mandibular advancement, in accordance with embodiments. Inthis approach, the practitioner uses a suitable measurement tool (e.g.,a protrusion or displacement gauge 800 such as a George Gauge) to obtainmeasurements of the patient's bite characteristics. For instance, thepractitioner can measure the amount of advancement (protrusion) of thepatient's lower jaw 802 relative to the upper jaw 804 in the normal biteposition, as well as the amount of maximum voluntary protrusion 806 thepatient can produce. As with all other types of measurement datadescribed herein, the advancement amount can be measured while thepatient is awake and/or during sleep, as desired. In some embodiments,the amount of mandibular advancement to be applied is determined basedon these measurements, e.g., as a percentage of the maximum voluntaryprotrusion such as about 60% of the maximum voluntary protrusion. Thisapproach can be considered to be a “one-dimensional” approach, in thatdisplacement is the only factor considered when determining the degreeof jaw advancement.

In some embodiments, purely displacement-based approaches may not beoptimal with respect to predicting whether the applied amount ofmandibular advancement will cause patient discomfort and otherundesirable side effects. Accordingly, certain embodiments presentedherein consider other parameters in addition to or instead ofdisplacement, such as an amount of force (e.g., anterior-posteriorforce) exerted upon the patient's jaws during mandibular advancement.This information can be used to design an appliance customized to exertan amount of force that is appropriate for the particular patient'streatment, e.g., in terms of reducing discomfort, tooth repositioning,etc.

FIG. 9 illustrates a force and displacement-based approach fordetermining an amount of mandibular advancement, in accordance withembodiments. In this approach, the practitioner uses a measurement tool900 that is capable of measuring the anterior-posterior force applied tothe patient's jaws (e.g., via a force sensor or transducer 902) as wellas the amount of displacement of the lower jaw 904 relative to the upperjaw 906 (e.g., via an advancement gauge or protrusion gauge 908). Insome embodiments, the measurement data is a one-dimensional measurement,e.g., the force and/or displacement are measured along theanterior-posterior direction only. Alternatively, the measurement datacan be taken with respect to more than one dimension. For example, a sixdegree of freedom measurement can be obtained that measures the forcealong a plurality of different directions in addition to theanterior-posterior direction (e.g., using a six degree of freedom loadcell). In some embodiments, other measurement devices besides forcesensors are used to obtain force data. For example, electromyography(EMG) measurements of the jaw muscles can be used to measure muscleactivity. The EMG data can be input into a biomechanical model of theTMJ system in order to estimate the magnitudes of forces generated.Similarly, jaw displacement can be measured along more than onedirection, e.g., using a three degree of freedom gauge that measuresdisplacement along the anterior-posterior, vertical, and/or lateraldirections. Alternatively or in combination, six degree of freedomkinematics of the jaws can be determined using other methods, such asultrasound sensing and/or tracking of reflective markers placed on thejaws.

The measurement data described herein can be taken while the patient isawake and/or asleep, as desired. In some embodiments, the approachesprovided herein account for the differences in muscle activity duringsleep versus wakefulness. Certain patterns of muscle activation can beunique to sleep, such as rhythmic masticatory muscle activity and/orbruxism. In some embodiments, it may be more physiologically relevant toobtain force and/or displacement measurements while the patient issleeping. For example, sleep data such as EMG data and/or otherpolysomnographic (PSG) data can be used as an input for designing theappliances presented herein. The sleep data can be used to directlyprovide force measurements during sleep, for instance. Alternatively,force measurements can be obtained while the patient is awake, and thesleep data can be used to calibrate the force measurements to accountfor the differences in physiology during wakefulness versus sleep.Various methods can be implemented in order to calibrate forcemeasurements taken while the patient is awake using the sleep data. Insome embodiments, the ratio between the maximum and/or average forcevalues obtained during wakefulness versus sleep can be determined. Theratio can be indicative of the relative muscle activation levels whenthe patient is awake versus when the patient is asleep, for example. Insome embodiments, the muscle activation may be higher during sleep,while in other embodiments, the muscle activation may be higher duringwakefulness. Force values obtained while the patient is awake can thenbe scaled according to the ratio to determine the corresponding forcevalues during sleep. Alternatively or in combination, a biomechanicalmodel of the jaws can utilize sleep data such as EMG data to predictforce values during sleep and/or wakefulness in order to calibrate theforce measurement data as discussed herein.

Optionally, the force measurement can be combined with other types ofdata, such as jaw geometry measurements (e.g., obtained by cone beamcomputed tomography, panographic x-rays, cephalograms, etc.) to predictforces at other locations near the patient's teeth and jaws, such as theTMJ region. Alternatively or in combination, the forces can be predictedfrom a biomechanical model of the jaws (e.g., with anatomical inputs ofthe jaws, muscle activation measurement, and/or anatomical statistics),with or without using measurement data from a force sensor. The forcedata can be used to determine the relationship between the anteriordisplacement amount and the anterior-posterior force applied to theteeth, e.g., as depicted in the force versus displacement curve 910. Therelationship between anterior-posterior force and displacement may be alinear relationship, for example. The force-displacement relationshipmay vary from patient to patient, e.g., due to patient-specificdifferences in jaw anatomy, jaw kinematic data, etc. The determinedrelationship can then be used as a basis for developing patient-specificmandibular advancement appliances. In some embodiments, the measurementdata is used to develop a force versus displacement model for thepatient that can be used to predict the amount of force associated witha given jaw protrusion input. This approach can be considered to be a“two-dimensional” approach, in that two factors (force and displacement)are considered.

FIG. 10 illustrates a force-based approach for determining an amount ofactivation for a mandibular advancement appliance, in accordance withembodiments. Activation may be used herein to refer to forces and/ormoments to be applied to one or more teeth by the appliance. Thepatient-specific force measurements described herein can also be used todetermine an amount of activation and/or anchorage that is applied toindividual teeth in order to reduce unwanted tooth repositioning. Theamount of anterior-posterior force applied to a tooth may be linearlyrelated to the amount of activation and/or anchorage that should beapplied to the tooth to prevent repositioning, e.g., as depicted in theforce versus activation/anchorage curve 1000. This relationshipinformation can be used as a basis for intraoral appliance design.

In some embodiments, a laboratory model of the teeth 1002 can be used todetermine the relationship between anterior-posterior force andactivation and/or anchorage. In some embodiments, the laboratory modelis used to predict force distributions that can inform the force and/ormoment activations to be applied to the teeth. The laboratory model canprovide a black box transfer function with jaw displacement and theassociated anterior-posterior forces (e.g., forces measured in vivo) asinputs, and the resultant force distribution on the teeth as an output.Various types of laboratory models are suitable for use with theembodiments presented herein. For example, the laboratory model caninclude physical tooth models coupled to load cells. As another example,the laboratory model can be a computer simulation with virtual toothmodels.

FIG. 11 illustrates a method 1100 for producing an intraoral appliancefor treating sleep apnea in a patient, in accordance with embodiments.One or more steps of the method 1100 can be performed by one or moreprocessors, e.g., one or more processors of a computer system configuredfor designing appliances. Alternatively or in combination, one or moresteps can be performed by a treating professional such as an orthodonticpractitioner. The method 1100 can be used to produce any of theappliances described herein.

In step 1110, a threshold force value is determined for an amount ofanterior-posterior (A-P) force that would be applied to the patient'steeth in order to displace the patient's lower jaw anteriorly relativeto the upper jaw. The threshold force value can be no greater thanamount of anterior-posterior force that is associated with side effectssuch as patient discomfort, undesirable tooth repositioning, and/or TMJdysfunction. For example, the threshold value can be about 1 N, 2 N, 5N, 10 N, 15 N, 20 N, or 25 N, or within a range from about 0.5 N toabout 20 N. The threshold value can be a standardized value that isapplied to most or all patients. Alternatively, the threshold value canbe customized for each particular patient, e.g., based on theforce-displacement measurements described herein.

In step 1120, a geometry for an intraoral appliance is determined basedon the threshold force value, such that the appliance is configured toapply an amount of anterior-posterior force to the patient's teeth thatis no greater than the threshold force value. In some embodiments, theintraoral appliance is configured to displace the lower jaw anteriorlyrelative to the upper jaw when worn by the patient in order to treat thesleep apnea. For instance, the appliance can include an upper shell withan upper advancement structure and cavities for receiving the upperteeth, and a lower shell with a lower advancement structure withcavities for receiving the lower teeth, with the upper and loweradvancement structures being arranged to engage each other to producemandibular advancement, as discussed herein. Optionally, the appliancecan have cavity geometries shaped to reduce undesirable toothrepositioning elicited by the advancement, as described herein.

The geometry of the appliance (e.g., the geometry of the tooth-receivingcavities and/or advancement structure(s)) can be determined in variousways. In some embodiments, the geometry can be determined based onreceived measurement data indicative of a patient-specific relationshipbetween the anterior displacement amount and the amount ofanterior-posterior force applied to the teeth, as described herein. Thisrelationship can be used to determine a threshold displacement valuecorresponding to the threshold force value, and the appliance can beconfigured to advance the lower jaw by an amount no greater than thethreshold displacement value.

In alternative embodiments, rather than using a threshold force valuethat serves as an upper limit on the amount of force to be applied tothe teeth, a target force value can be determined for an amount ofanterior-posterior (A-P) force that would be applied to the patient'steeth in order to displace the patient's lower jaw anteriorly relativeto the upper jaw. The target force value can be an amount ofanterior-posterior force that does not produce side effects such aspatient discomfort, undesirable tooth repositioning, and/or TMJdysfunction. For example, the target force value can be about 1 N, 2 N,5 N, 10 N, 15 N, 20 N, or 25 N, or within a range from about 0.5 N toabout 20 N. Accordingly, the appliance geometry (e.g., cavitygeometries) can be determined based on the target force value, such thatthe appliance is configured to apply an amount of anterior-posteriorforce to the patient's teeth that substantially matches the target forcevalue (e.g., is within 20%, 10%, 5%, 1%, 0.5%, 0.1%, or 0.01% of thetarget force value). Optionally, a target displacement valuecorresponding to the target force value can be determined, and theappliance can be configured to advance the lower jaw by an amountsubstantially matching the target displacement value (e.g., is within20%, 10%, 5%, 1%, 0.5%, 0.1%, or 0.01% of the target displacementvalue).

Alternatively or in combination, a method for producing an intraoralappliance for treating sleep apnea can involve determining the forces(e.g., anterior-posterior forces) applied to the upper and/or lower jawsat a targeted or optimal displacement amount for treating sleep apnea.The displacement amount can be based on patient-specific factors such asanatomy, jaw kinematics, sleep apnea severity, patient comfort, and thelike. The forces used to produce the displacement amount can bedetermined in various ways, e.g., by in vivo measurements and/or themodeling approaches described herein. Subsequently, the mandibularadvancement appliance can be designed using these forces as an input.

In some embodiments, the appliance design methods described herein alsoaccount for other forces applied on the patient's teeth besidesanterior-posterior forces. For example, a suboptimal vertical orocclusal force distribution can also influence the incidence of sideeffects such as jaw stability, TMJ dysfunction, and unintentional toothrepositioning. Accordingly, appliances herein can be designed to improvethe distribution of occlusal forces on the teeth, e.g., by distributingocclusal forces across a larger number of teeth, reducing occlusalforces on anterior teeth, increasing occlusal forces on posterior teeth,or combinations thereof. For example, the appliance can include occlusalstructures situated at various points along the arch in order to createadditional occlusal contact points that facilitate distribution ofocclusal forces. As another example, in some embodiments, inappropriateocclusal contacts between teeth (e.g., anterior occlusal contacts) cancreate instability, and occlusal structures can be used to shift theocclusal load to a more appropriate region of the dental arch (e.g., theposterior teeth) in order to improve stability.

In some embodiments, occlusal structures (e.g., platforms, ramps,protrusions, etc.) are placed on the appliance to create contact pointsindependent of the anterior-posterior axis. For example, the occlusalstructures can be parallel or substantially parallel to the occlusalplane to create controlled contact points normal to the occlusal plane.This can be used to strategically distribute occlusal loads or toposition the mandible in the vertical dimension (e.g., to control theamount of mouth opening). The occlusal structures can be ramped at anangle offset from the occlusal plane to provide a lateral component tothe contact. Such occlusal structures can be positioned and angled torecreate or mimic aspects of normal healthy occlusion, such as canineguidance. In some embodiments, the occlusal structures can mimic thenatural intercuspation of the teeth, e.g., by incorporating surfacegeometries that mimic the geometries of the cusps on the teeth (e.g.,molar cusp geometries). The intercuspated surface geometries can beoffset relative to the patient's actual tooth geometry in order toaccommodate the protruded mandibular position. The use of suchintercuspated surface geometries can facilitate application of occlusalloads at the desired locations (e.g., on the posterior teeth).

FIGS. 23A through 23C illustrate optimizing occlusal force distributionon the teeth, in accordance with embodiments. In the appliance 2300, theupper shell 2302 and lower shell 2304 produce mandibular advancement viathe engagement of upper and lower advancement structures 2306, 2308. Insome embodiments, when the mandible is in the advanced position, theocclusal contact points between the upper and lower teeth are primarilylocated on the anterior teeth, thus producing a region of relativelyhigh occlusal pressure 2310. This can create an unequal occlusal force(force along the vertical axis) that can result in problems with respectto jaw stability, TMJ dysfunction, and unwanted tooth movements.

FIG. 23B illustrates a modified appliance 2320 in which posteriorocclusal structures 2322, 2324 have been added to the upper and lowershells 2302, 2304, respectively in order to create additional posteriorocclusal contact points to distribute the occlusal forces onto theposterior teeth and away from the anterior teeth. The appliance 2320 caninclude two pairs of such occlusal structures, e.g., one on the leftside and one on the right side. FIG. 23C illustrates a posterior view ofthe region 2326 of the appliance 2320 (indicated by the dashed circle inFIG. 23B). The various characteristics of the posterior occlusalstructures 2322, 2324 can be varied as desired in order to create adesired amount of vertical space between the jaws, reduce lateral jawmovements, and/or create three-dimensional movements in order to reflectthe actual movement of the jaw when extended during sleep. For example,the height 2328 of the occlusal structures 2322, 2324 can be increasedor decreased as desired to accommodate the natural occlusal separationbetween the jaws during sleep (e.g., if the patient is an open breatherwho sleeps with the mouth open). In embodiments where two pairs ofocclusal structures are used (e.g., a left pair and a right pair), theheights of the two pairs can be the same (e.g., to provide symmetry) ordifferent (e.g., to control rotation of the mandible about theanterior-posterior axis). As another example, the angle 2330 of theinterface between the occlusal structures 2322, 2324 can be varied inorder to control the extent of permitted lateral movements of the jawsrelative to each other. In some embodiments, a larger angle inhibitslateral movements while a smaller angle permits lateral movements.Optionally, the angle 2330 can be used to control the amount of verticalopening dependence on lateral motion, similar to canine guidance duringlateral jaw motions. In such embodiments, the occlusal structures 2322,2324 can be used to preferentially distribute lateral loads on thecanines in order to avoid unwanted lateral loading of the molars duringlateral mandibular movements, e.g., by positioning the occlusalstructures over the canines. In some embodiments, angulated occlusalstructures are used to control and/or guide the lateral motions of thejaws while permitting jaw opening and/or jaw closing motions. Constraintof lateral jaw movements can increase the stability with which the jawsare maintained in the specified position, thus reducing the likelihoodof the upper and lower shells 2302, 2304 becoming inadvertentlydisengaged from each other during sleep due to lateral motion.

In some embodiments, the appliance design approaches presented hereininvolve modifying one or more parameters of an advancement structure inorder to produce a desired amount of mandibular displacement and/ordisplacement force. As discussed herein, an appliance can include anadvancement structure that engages with an opposing jaw (e.g., directly,or indirectly via a second advancement structure) to produce theprotrusive force that advances the lower jaw. The shape and/or positionof the advancement structure can determine the extent to which the jawis displaced and the stability with which the jaw is maintained in theadvanced position. Additionally, the configuration of the advancementstructure can influence patient comfort, as larger amounts of jawdisplacement and/or constraint of jaw movement can increase discomfort.Accordingly, the placement, positioning, and/or geometry (e.g., size,shape) of mandibular advancement structures on the shells of intraoralappliances can be optimized, e.g., in order to maximize mandibularadvancement distance, mandibular advancement stability, and/or patientcomfort.

Various methods can be used to produce the optimized appliancesdescribed herein. In some embodiments, an appliance can be produced withcustomized advancement structures having a specified position and/orgeometry to produce a desired jaw configuration. In other embodiments,the mandibular advancement appliances described herein can be fabricatedwith generic advancement structures that can be subsequently adjusted bythe treating professional to the desired position and/or geometry inorder to produce the desired jaw configuration. For instance, anadjustable appliance can include an advancement structure with one ormore movable portions that can be moved relative to the appliance inorder to modify the position and/or geometry of the advancementstructure. As another example, an adjustable appliance can include anadvancement structure with one or more removable portions that can beadded or removed from the appliance to produce a desired geometry. Insuch embodiments, the structure can include markings to indicate theportion(s) that should be added or removed to produce a certain amountof displacement. For example, an appliance can include a mandibularadvancement structure having removable portions that can be used toalter the thickness and/or shape of the structure in order to achieve adesired amount of movement for a given treatment stage. The structurecan include markings indicating how much of the structure should beremoved to achieve a desired amount of jaw advancement. In someembodiment, the treating professional is provided with a plurality ofadjustable appliances and makes different adjustments to each one inorder to create a series of appliances that produce differing degrees ofmandibular advancement.

FIG. 12 illustrates optimizing the position of an advancement structure,in accordance with embodiments. In the depiction of FIG. 12, themandibular advancement appliance 1200 comprises an upper shell 1202 andlower shell 1204 with respective protruding advancement structures 1206,1208, similar to the embodiment of FIG. 2. The advancement structures1206, 1208 engage with each other when the shells 1202, 1204 are broughttogether (e.g., when the patient's jaws are closed) to advance themandible anteriorly. As shown in FIG. 12, the degree of mandibularadvancement can be be controlled by relative positioning of theadvancement structures 1206, 1208 along the upper and lower shells 1202,1204 and/or the centerline-to-centerline distance 1210 between theadvancement structures 1206, 1208. In some embodiments, the degree ofmandibular advancement can be determined by the positioning of the upperand lower mandibular advancement structures 1206, 1208 on theirrespective arches. For a given relative jaw position, the lower jawmandibular advancement structure 1208 can be placed more posteriorly inorder to increase the mandibular advancement. Accordingly, thepositioning of the upper advancement structure 1206 and/or the loweradvancement structure 1208 can be varied in order to achieve a desiredamount of jaw displacement. For example, in the depiction of FIG. 12,the lower shells 1204, 1212, 1214, 1216 each have a respectiveadvancement structure that is located at a different position along theanterior-posterior axis of the appliance. Each lower shell 1204, 1212,1214, 1216 can produce a different amount of mandibular advancement whenworn with the upper shell 1202. The shells 1204, 1212, 1214, and 1216can be configured to produce increasing amounts of advancement up to amaximum or targeted advancement amount 1218.

In some embodiments, a mandibular advancement system is provided thatincludes a primary appliance (e.g., a shell appliance worn on one jaw)and a plurality of secondary appliances (e.g., shell appliances worn onthe opposing jaw) useful for selectively achieving different degrees ofmandibular advancement. Each secondary appliance can produce a differentamount of jaw advancement when engaged with the primary appliance.Accordingly, different secondary appliances can be sequentially appliedto the patient, for example, to titrate for an optimal or targetedamount of mandibular advancement, or to produce incremental stagingtowards a targeted or optimal advanced position to mitigate patientdiscomfort. In some embodiments, the patient can select which of thesecondary appliances is preferred for treatment.

For example, during the diagnostic stage, an optimal or targetedmandibular advancement amount can be determined for the patient. Asystem of oral appliances can be fabricated and delivered to the doctor,e.g., using the scanning and fabrication procedures as are well known inthe art as described further herein. Alternatively or in combination, aplurality of upper shells configured to be worn with a lower shell canbe fabricated. This allows for the production of a set of intraoralappliances including a single upper or lower appliance shell with aplurality of mating appliance shells, where the advancement structure onthe mating shell is slightly offset from the structure on the othershells, e.g., by a distance in the range from about 0.1 mm to about 1mm. The patient can then wear the shell with the fixed advancementstructure and choose from the plurality of mating shells to achieve adesired degree of mandibular advancement. To make an adjustment to themandibular advancement dosage, only one of the shells (e.g., the lowershell) need be replaced. The treatment can thus be adjusted by thepatient between visits to the physician and/or fabrication of newappliances.

Alternatively or in combination with the position-based customizationdescribed herein, the geometric parameters of the advancement structurecan also be modified, e.g., based on patient-specific factors and/or thedesired treatment regimen. Examples of such geometric parameters includebut are not limited to structure height, width, thickness, angle, andshape. By adjusting the geometry of the advancement structure,appliances can be designed in a patient-specific manner to produce aspecified jaw configuration (e.g., amount of mandibular advancement,amount of vertical distance between upper and lower jaws, etc.).

FIGS. 13A through 13D illustrate optimizing the geometry of anadvancement structure, in accordance with embodiments. Similar to theembodiment of FIG. 12, the mandibular advancement appliance includes alower shell 1302 and upper shell 1304 with respective protrudingadvancement structures 1306, 1308. The advancement structures 1306, 1308include respective engagement surfaces shaped to engage with each otherin order to urge the lower jaw anteriorly. In some embodiments, theengagement surface 1310 is characterized by an inclination angle 1312that indicates the extent to which the surface 1310 is rotated from thevertical axis 1314. For example, an inclination angle of 0° (see, e.g.,FIG. 13C) can indicate that the engagement surface is parallel to thevertical axis and perpendicular to the anterior-posterior axis, whereasan inclination angle of 30° (see, e.g., FIG. 13D) can indicate that theengagement surface is at an angle relative to the vertical axis. Pairedadvancement structures can have engagement surfaces with the sameinclination angle in order to facilitate mating of the engagementsurfaces.

In some embodiments, the inclination angle influences various treatmentparameters such as the mandibular advancement amount, advancementstability, and degree of discomfort experienced by the patient. Forinstance, a larger inclination angle can produce a larger amount ofmandibular displacement while a smaller inclination angle can produce asmaller amount of displacement. As another example, advancementstructures with a larger inclination angle can be more prone to becomingdisengaged and therefore can be less stable than structures with smallerinclination angles. In yet another example, a larger inclination anglecan be associated with increased patient comfort, e.g., due to reducedresistance to certain jaw movements such as jaw opening movements, whilea smaller inclination angle can be associated with decreased patientcomfort, e.g., due to increased jaw opening resistance. The correlationsbetween inclination angle and treatment parameters can vary based on thespecific anatomy and kinematics of the patient's jaw. Accordingly, theinclination angle for an engagement surface can be determined based onany suitable combination of the patient's jaw anatomy, jaw kinematicdata, targeted displacement distance, or targeted amount of patientcomfort. In some embodiments, the inclination angle can be based on thespecific anatomy of the muscles in and around the jaw, such as theexternal pterygoid muscle 1320, masseter muscle 1322, and/or geniohyoid,mylohyoid, and digastric muscles 1324 (arrows indicate directionality ofthe muscles).

Optionally, the inclination angle can be designed based on the patient'shabitual jaw opening trajectory 1316. An appliance with an inclinationangle that more closely corresponds to the angle of the trajectory (see,e.g., FIG. 13D) can be more comfortable to wear than one that has anangle different from the trajectory (see, e.g., FIG. 13C), due toreduced resistance of the advancement structures to jaw opening andclosing movements. However, such appliances can be more susceptible tobecoming inadvertently disengaged.

FIG. 14 illustrates loss of mandibular advancement due to disengagementof advancement structures, in accordance with embodiments. Themandibular advancement device of FIG. 14 includes a lower shell 1402 andupper shell 1404 with respective protruding advancement structures 1406,1408 configured to engage each other, similar to other embodimentsdescribed herein. In some embodiments, the advancement structures 1406,1408 become disengaged during use, e.g., due to passive mouth opening ofthe patient (see, e.g., arrow 1410). For example, during sleep, the jawmay tend to open for some patients. Disengagement of the structures1406, 1408 can result in the reversion of the mandible to the habitualconfiguration, thus compromising the effectiveness of the sleep apneatreatment.

Accordingly, various embodiments of the intraoral appliances providedherein include a coupling mechanism to prevent inadvertent disengagementof advancement structures, as well as to bias the advancement structurestoward a targeted arrangement in order to maintain a desired jawconfiguration (e.g., with respect to amount of mandibular advancement,jaw opening distance, etc.). In some embodiments, the coupling mechanismincludes a first coupling element of an upper advancement structure ofan upper appliance shell, and a second coupling element of a loweradvancement structure of a lower appliance shell. The coupling elementscan include, for example, magnetic elements, elastic tethers, matingfeatures, adhesive components, or combinations thereof. The first andsecond coupling elements can interact with each other to maintain theupper and advancement structures in engagement with each other.Alternatively or in combination, the coupling elements can be arrangedto bias the advancement structures toward predetermined relativepositions, e.g., to produce an optimal jaw configuration for treatingsleep apnea while mitigating discomfort. In some embodiments, thisbiasing is reversible, such that the patient is able to disengage thestructures if sufficiently large movements and/or forces are applied(e.g., in order to remove the appliance). The use of reversible biasingelements can improve comfort and ease of use of the appliance byallowing for voluntary separation of the patient's jaws, while providingresistance to involuntary disengagement during treatment.

In some embodiments, to promote engagement of advancement structures,magnets can be embedded into the advancement structures as shown invarious embodiments herein. The number, strength, andposition/orientation of magnets on the advancement structures may all beselected to provide particular treatments for individual patients. Insome embodiments, in contrast to other uses of magnets in mandibularadvancement devices, the embodiments herein do not use magnetism toeffect advancement, but rather use magnetism to properly position theupper and lower appliance shells as well as to promote closed-mouthsleeping, which can be desirable for device effectiveness and forhealthy oral hygiene. In some embodiments, the magnets not only allowthe advancement structures to prevent mandibular retrusion (retraction),but can also be positioned to allow or eliminate any vertical gapbetween the upper and lower shells, allowing an additional treatmentvariable for particular patients. The use of magnetic elements in theappliances described herein is particularly advantageous in someembodiments since they are able to stabilize the jaws at a desiredposition while allowing the jaws to periodically open, close, andcomfortably return to the correct positions. Additionally, the strengthof the magnetic elements can be varied to achieve a desired degree ofstabilization, with stronger magnets promoting retention.

FIG. 15A illustrates a magnetic coupling for advancement structures, inaccordance with embodiments. FIGS. 15B and 15C illustrates sagittal andfrontal views of the magnetic coupling of FIG. 15A, respectively. Theappliance 1500 includes upper and lower shells 1502, 1504 that engageeach other via respective advancement structures 1506, 1508 to advancethe mandible. In some embodiments, the structures 1506, 1508 have matinganterior and posterior surfaces, respectively, that mate along anengagement plane 1510 to effect the advancement. The inclination angleof the engagement plane 1510 relative to the vertical axis can be variedaccording to patient-specific factors and the prescribed treatment plan,as discussed herein. The upper structure 1506 can include an uppermagnetic element 1512 and the lower structure 1508 can include a lowermagnetic element 1514. The magnetic elements 1512, 1514 can bepositioned near the engagement plane 1510 and arranged such that theattractive magnetic forces reversibly bias the structures 1506, 1508towards the engaged configuration. By comparing FIGS. 15A through 15C,it can be seen that by adjusting (1) the angle of the engagement plane1510 relative to a transverse plane passing between the jaws and (2) thepositions of the magnetic elements 1512, 1514 along the engagement plane1510 (e.g., in a generally upward or downward direction), the amount ordistance of the mandibular advancement can be controlled as well, as themagnitude of the gap between the upper and lower shells 1502, 1504.

FIG. 16A illustrates an alternative magnetic coupling for advancementfeatures, in accordance with embodiments. The appliance 1600 includesupper and lower shells 1602, 1604 that engage each other via respectiveadvancement structures 1606, 1608 to advance the mandible. The upper andlower structures 1606, 1608 engage each other along anterior andposterior surfaces, respectively. Additionally, the upper structure 1606includes an extended base portion 1610 that contacts and engages anupper surface 1612 of the lower structure 1608. In some embodiments, anupper magnetic element 1614 is positioned near the base portion 1610 anda lower magnetic element 1616 is positioned near the upper surface 1612,the attractive magnetic forces reversibly bias the structures 1606, 1608towards the engaged configuration. This arrangement of magnetic elementscan provide increased resistance to disengagement during mouth openingcompared to other arrangements.

FIG. 16B illustrates a magnetic coupling with self-centeringcapabilities, in accordance with embodiments. The magnetic coupling issimilar to that of FIG. 16A, except that the upper and lower magneticelements 1618, 1620 have different lengths. In the depicted embodiment,the lower magnetic element 1620 is shorter than the upper magneticelement 1618, although it shall be appreciated that the lower element1620 can be longer than the upper element 1618 in alternativeembodiments. The self-centering tendencies of the magnetic elements1618, 1620 can produce an attractive force having a posteriorly-directedcomponent (see, e.g., arrow 1622), thus exerting a posterior force onthe lower advancement structure 1608 that biases it towards the engagedposition with the upper advancement structure 1606. This arrangement canfurther improve the stability of the engagement between the upper andlower advancement structures 1606, 1608.

FIG. 16C illustrates adjustments to the geometry of a magnetic coupling,in accordance with embodiments. The angle 1624 between the base portion1610 and upper surface 1612 where the magnetic elements 1614, 1616 arelocated can influence the stability of the engagement between the upperand lower advancement structures 1606, 1608. For example, the angle 1624can be adjusted to be approximately normal to the patient's mouthopening trajectory to facilitate disengagement during mouth openingmovements.

Alternatively or in combination with the magnetic coupling mechanismsdescribed herein, an intraoral appliance can utilize other types ofcoupling mechanisms to control the relative positioning of the jaws. Forexample, a mechanical coupling mechanism can include features shaped tomate with each other in order to promote advancement stability. Suchfeatures can include one or more of grooves, protrusions, receptacles,recesses, cavities, apertures, ribs, flanges, and the likes. Thefeatures can be arranged to mate when the advancement structures areengaged, thus reducing the likelihood of inadvertent disengagement.Additionally, the positioning of the features can be used to control theadvanced configuration of the jaws, e.g., in terms of advancementposition and vertical separation.

FIG. 17A illustrates a mechanical coupling for advancement structurescomprising a cup and ball mechanism, in accordance with embodiments. Inthe embodiment of FIG. 17A, the appliance includes a first matingfeature, e.g., a cup or detent 1702, formed on an engagement plane of anadvancement structure 1704 and a second mating feature, e.g., a ball orrod 1706, on the other shell 1708. The second mating feature can engagethe first mating feature, e.g., by seating in the cup or detent 1702formed on the advancement structure 1704.

FIG. 17B illustrates a mechanical coupling for advancement structurescomprising textured surfaces, in accordance with embodiments. In theembodiment of FIG. 17A, the appliance includes a first textured surface1720 on a first advancement structure 1722 and a second textured surface1724 on a second advancement structure 1726. The textured surfaces 1720,1724 can include complementary features such as patterned grooves thatmate with each other when the first and second advancement structures1722, 1726 are engaged with each other.

Alternatively or in combination, the coupling mechanism can includefasteners, e.g., tethers, clasps, and the like, that constrain themovement of the advancement structures relative to each other. Thefasteners can include some degree of compliance to accommodate smallmovements of the jaws while maintaining the overall advanced position ofthe mandible. In other embodiments, the fasteners can be relativelystiff so as to provide increased control over the relative positions ofthe advancement structures.

FIG. 17C illustrates elastic tethers 1730, 1732 for coupling advancementstructures, in accordance with embodiments. Although FIG. 17C depicts apair of tethers 1730, 1732, it shall be appreciated that the number oftethers can be varied as desired. Each elastic tether includes one endcoupled to the upper shell 1734 and an opposing end coupled to the lowershell 1736. The positions and orientations of the elastic tethers 1734,1736 can be varied as desired to control the resultant jawconfiguration. For example, the end coupled to the upper shell 1734 canbe positioned posteriorly relative to the end coupled to the lower shell1736 such that the elastic forces in the elastic tether 1730, 1732 pullthe upper and lower advancement structures 1738, 1740 into engagementwith each other. In some embodiments, the tethers 1730, 1732 arearranged to be at their natural length 1742 (undeformed length) when thestructures 1738, 1740 are correctly engaged. In other embodiments, thetethers 1730, 1732 are stretched longer than their natural length 1742when the structures 1738, 1740 are engaged, such that tensile forces areapplied to the structures 1738, 1740 in the engaged configuration.

Optionally, the intraoral appliances described herein can be configuredto accommodate natural asymmetries in the patient's jaw configuration.In some embodiments, due to asymmetries in the neuromuscular andskeletal system of the jaw, the jaw advancement trajectory that is mostcomfortable for the patient may not necessarily be uniaxial (e.g.,solely along the anterior-posterior axis). For example, the advancedposition may include lateral translations or shifts (e.g., along aleft-right direction), rotations (e.g., within a sagittal plane), orcombinations thereof. Additionally, the comfortable advanced positionmay be influenced by asymmetrically stretched muscles.

FIGS. 24A through 24C illustrate occlusal views of symmetric andasymmetric jaw advancement, in accordance with embodiments. FIG. 24Aillustrates a symmetric advancement position in which the mandible 2400is displaced solely in an anterior direction, as indicated bydisplacement vector 2402. FIG. 24B illustrates an asymmetric advancementposition in which the mandible 2404 is displaced anteriorly with alateral shift, as indicated by displacement vector 2406. FIG. 24Cillustrates an asymmetric advancement position in which the mandible2408 is rotated during advancement, as indicated by displacement vector2410.

In embodiments where the patient's jaws exhibit natural asymmetries, amandibular advancement appliance that produces uniaxial advancement maycause asymmetric stretching of the jaw muscles, which may lead to sideeffects such as jaw discomfort, muscle strain, TMJ dysfunction, and/orbite alterations. Accordingly, it can be beneficial to designadvancement appliances that advance the mandible in a manneraccommodating the asymmetries of the patient's anatomy. This can beachieved, for instance, by designing the position and/or geometries ofthe mandibular advancement structures to produce asymmetric advancementcorresponding to the patient's natural jaw asymmetries.

FIGS. 25A and 25B illustrate optimizing appliance design to accommodatea patient's jaw asymmetry, in accordance with embodiments. FIG. 25Aillustrates a frontal view of an appliance 2500 which produces symmetricjaw advancement along the anterior-posterior axis, as indicated byalignment of the midlines of the upper shell 2502 and lower shell 2504.The mandible can be constrained to advance in a symmetric manner by theposition and/or geometry of the advancement structures of the appliance2500. FIG. 25B illustrates a frontal view of an appliance 2510 whichproduces asymmetric advancement, as indicated by a lateral shift 2512between the midlines of the upper shell 2514 and lower shell 2516. Thiscan be achieved, for instance, by designing the position and/or geometryof the advancement structures (e.g., depicted herein as fin-likestructures on the buccal surfaces of the shells 2514, 2516) to allow fora lateral shift of the mandible as it is advanced relative to themaxilla. Alternatively or in combination, the advancement structures canbe designed to place and/or constrain the mandible in a specifiedposition (e.g., a position that is more comfortable for the patient).For example, the structures can include one or more lateral contactpoints to constrain lateral motion of the jaws. As another example, thepositioning of the structures can be used to control the rotation of themandible about the vertical axis.

In order to produce mandibular advancement devices that are customizedto the patient, the appliance design and fabrication methods describedherein may involve obtaining measurement data of the patient's jawanatomy and/or jaw kinematics while the patient is awake. Alternatively,some or all of the measurement data described herein can be obtainedwhile the patient is asleep, if desired. Various methods can be used toensure the accuracy of such measurements. In some embodiments, digitalscanning techniques are used to determine the spatial relationshipbetween the patient's upper and lower jaws in a desired advancedposition (e.g., while the patient is awake), and the appliance can befabricated based on the spatial relationship data. For example, thepatient's mandible jaw can be positioned and settled in a desiredadvanced position while the patient is awake (e.g., a position that ismost comfortable and relaxed for the patient.) using a protrusion gauge.This can be facilitated, for instance, through the use of a physicaldevice (e.g., retention materials, wax materials, and/or an adjustable3-contact mechanism) to position the patient's jaw to a desiredposition. The patient's jaws can then be scanned while in the advancedposition in order to measure the spatial relationship of the lower jawwith respect to the upper jaw while the patient is awake. In someembodiments, a physical device for positioning the patient's jaw may berelatively bulky and difficult to use with a scanner, unless a cone beamscanner or X-ray scanner is used to scan an image of the intraoralcavity. Alternatively or in combination, kinematic measurement data ofthe patient's jaws can be obtained, e.g., by placing reflective markerson certain locations on or near the jaws and performing digital scanningof the jaws at various advanced positions while is awake. In suchembodiments, the kinematic measurement data can be mapped back to amodel of the jaws (e.g., a skeletal model) in order to accuratelypredict the spatial relationship between the jaws at any advancedposition.

Optionally, the design of the appliances provided herein (e.g., withrespect to application, shape, position, size, etc. of the structures)can be dependent on various inputs. In some embodiments, the inputs arerelated to the patient's TMJ. For instance, if the patient has a TMJdisorder, oral appliance therapy may not be recommended in somesituations. Alternatively, a force-limited appliance as discussed hereincan be used for patients with TMJ disorders, e.g., an applianceconfigured to produce forces no greater than a physiological thresholdthat is appropriate for patients with TMJ disorder. In some embodiments,the appliance is designed to permit asymmetrical joint kinematics inorder to accommodate natural and/or patient-specific TMJ asymmetries.For example, an appliance can include buccal structures (e.g., theadvancement structures discussed with respect to FIG. 25B) shaped and/orplaced to accommodate asymmetries associated with the TMJ. Variousmethods can be used to measure the patient's specific jaw asymmetry,including but not limited to facebow measurements, bite registrations,and/or ultrasound.

In some embodiments, the inputs for appliance design can include atargeted amount and/or maximum amount of anterior-posterior force to beexerted by the appliance. As described above and herein, a forcemeasurement can be made for the patient in order to determine apatient-specific force threshold for the appliance. Optionally, theforce system created by device activations can also be customized forthe patient if a force measurement was taken.

Various embodiments of the intraoral appliances described herein can beprovided as part of a mandibular advancement treatment for sleep apnea.In some embodiments, the present disclosure provides forpatient-specific treatment of sleep apnea using customized mandibularadvancement appliances. The appliances can be custom manufactured to fita patient's dentition, typically by scanning or taking an impression ofthe patient's dentition to allow obtain precise tooth position datafabricating retainer-like upper and lower plates. Relying on the toothdata and mandibular protrusion and preferably with some knowledge ofresulting anterior-posterior force, the appliances can be designed toapply force to the mandible while favorably distributing orthodonticforces applied to individual teeth which would result in unintendedmovement of the teeth relative to each other and the jaw. Exemplaryappliances according to the present disclosure may produce nosignificant teeth movements. A patient-specific limiting protrusion canbe designed into the device that is dependent on the anterior-posteriorforce generated by the mandibular protrusion in order to prevent adverseloading of the TMJ neuromuscular system.

FIG. 18 illustrates a method 1800 for planning a mandibular advancementtreatment, in accordance with embodiments. The method 1800 can be usedin conjunction with any of the appliances described herein. One or moresteps of the method 1800 can be performed by a treating professional,such as a dentist or orthodontist. At least some of the steps of themethod 1800 can be implemented using digital treatment planningsoftware, as described further herein.

In step 1810, the treating professional screens the patients for sleepapnea (e.g., OSA). Methods for performing sleep apnea screening areknown to those of skill in the art. In some embodiments, theprofessional can be supplied with a screening kit that includes toolsand/or guidance for performing the screening. For instance, a screeningkit can include a questionnaire, mobile application for testing,screening software, or other such tools for facilitating evaluation ofthe patient's condition.

In step 1820, the patient is diagnosed with sleep apnea, e.g., using ahome sleep test. The treating professional can obtain various types ofdata relevant to the patient's treatment, such as by assessing themaximum and/or optimal amount of mandibular advancement (e.g., withrespect to oxygen saturation, restoration of normal airflow, etc.) fortreating the sleep apnea. In some embodiments, additional measurementdata such as jaw kinematic data (e.g., jaw border movements, habitualjaw opening, maximum jaw opening), jaw anatomy, force-displacementrelationships, or data indicative of any of the patient-specific factorsdescribed herein can be obtained in step 1820.

In step 1830, one or more intraoral appliances for mandibularadvancement are designed and optimized. The step 1830 can involve, forexample, determining positioning and/or geometry of one or moremandibular advancement structures based on the diagnostic data obtainedin steps 1810 and 1820. The positioning and/or geometry can be optimizedfor patient comfort, mandibular advancement stability, and/or mandibularadvancement amount for effectively treating the sleep apnea, asdescribed herein. Additionally, the intraoral appliance(s) can be custommade for the patient's specific teeth and jaw anatomy, e.g., based onmeasurement data such as scanning data of the dentition and/or jaws. Insome embodiments, the intraoral appliance is designed to reduce oreliminate unwanted orthodontic loads that elicit undesirable toothrepositioning, as discussed herein.

In step 1840, the intraoral appliance is delivered to the patient.Optionally, the step 1840 can involve delivering a system of appliances,e.g., a set or series of appliances providing differing “dosages” ofmandibular advancement, as described herein. For patients who requiresevere mandibular advancement, a staged advancement can be delivered,for instance, using the system of FIG. 12 for optimal treatment. Forexample, the lower two lower appliance shells 1214, 1216 might representstages 1 and 2, respectively, of the treatment, with the other shellsbeing used successively to achieved a targeted mandibular advancementwhile mitigating patient discomfort.

Although the above steps show method 1800 of planning a mandibularadvancement treatment in accordance with embodiments, a person ofordinary skill in the art will recognize many variations based on theteaching described herein. Some of the steps may comprise sub-steps.Some of the steps can be combined with other steps. Many of the stepsmay be repeated as often as beneficial to the treatment. Some of thesteps may be optional, such as one or more of steps 1810 or 1820. Theorder of the steps can be varied. For example, steps 1810 and 1820 maybe performed in any suitable order.

In some embodiments, the mandibular advancement appliances describedherein can also be used to reposition one or more teeth in accordancewith an orthodontic treatment plan. For instance, an intraoral appliancecan include cavity geometries shaped to receive one or more teeth andreposition the one or more teeth from an initial tooth arrangementtowards a target tooth arrangement for the patient. Exemplary methodsfor designing and producing such appliances are described furtherherein. In some embodiments, some or all of the tooth-receiving cavitiesof a mandibular advancement appliance can include be shaped toreposition teeth to a target arrangement, while reducing or preventingunintentional tooth repositioning elicited by mandibular advancement asdiscussed herein. Optionally, some of the tooth-receiving cavities canbe shaped to maintain a current arrangement of some of the patient'steeth, thus reducing or preventing any tooth repositioning of thoseteeth. For example, an appliance can include some cavities shaped toreposition a subset of teeth according to a treatment plan and somecavities shaped to maintain a different subset of teeth in their currentpositions and orientations. In alternative embodiments, all of thetooth-receiving cavities are shaped to maintain the patient's teeth inthe current arrangement, such that the appliance serves as a retainerrather than a repositioning appliance.

In some embodiments, a mandibular advancement appliance can includetooth-receiving cavities that reposition one or more teeth towards atarget arrangement in order to treat sleep apnea. Various types oforthodontic treatments for alleviating sleep apnea can be implemented incombination with the embodiments presented herein. For example, anorthodontic treatment plan can involve repositioning one or more teethto increase the amount of space for the patient's tongue, such as one ormore posterior teeth. Arch expansion of the posterior teeth toaccommodate the volume of the tongue can allow the patient's tongue tomove forward in the intraoral cavity, which may improve airflow andreduce obstruction of the air passages during sleep. Examples ofposterior tooth movements that can be used to increase space for thetongue include but are not limited to tipping the crown in a buccaldirection, translational movements in a buccal direction, and extrusion.In some embodiments, the movements of the posterior teeth result inleveling of the patient's curve of Spee (the curvature of the occlusalplane along the cusps of the teeth) which can increase the amount ofroom for the tongue. The tooth repositioning movements described hereincan be applied to teeth of the lower jaw, upper jaw, or both jaws.

FIG. 19A illustrates an exemplary tooth repositioning appliance oraligner 1900 suitable for incorporation with the embodiments describedherein. The appliance 1900 can be worn by a patient in order to achievean incremental repositioning of individual teeth 1902 in the jaw. Theappliance can include a shell (e.g., a continuous polymeric shell or asegmented shell) having teeth-receiving cavities that receive andresiliently reposition the teeth. In one embodiment, an appliance orportion(s) thereof may be indirectly fabricated using a physical modelof teeth. For example, an appliance (e.g., polymeric appliance) can beformed using a physical model of teeth and a sheet of suitable layers ofpolymeric material. An appliance can fit over all teeth present in anupper or lower jaw, or less than all of the teeth. The appliance can bedesigned specifically to accommodate the teeth of the patient (e.g., thetopography of the tooth-receiving cavities matches the topography of thepatient's teeth), and may be fabricated based on positive or negativemodels of the patient's teeth generated by impression, scanning, and thelike. Alternatively, the appliance can be a generic appliance configuredto receive the teeth, but not necessarily shaped to match the topographyof the patient's teeth. In some cases, only certain teeth received by anappliance will be repositioned by the appliance while other teeth canprovide a base or anchor region for holding the appliance in place as itapplies force against the tooth or teeth targeted for repositioning. Insome cases, many or most, and even all, of the teeth will berepositioned at some point during treatment. Teeth that are moved canalso serve as a base or anchor for holding the appliance as it is wornby the patient. Typically, no wires or other means will be provided forholding an appliance in place over the teeth. In some cases, however, itmay be desirable or necessary to provide individual attachments or otheranchoring elements 1904 on teeth 1902 with corresponding receptacles orapertures 1906 in the appliance 1900 so that the appliance can apply aselected force on the tooth. Exemplary appliances, including thoseutilized in the Invisalign® System, are described in numerous patentsand patent applications assigned to Align Technology, Inc. including,for example, in U.S. Pat. Nos. 6,450,807, and 5,975,893, as well as onthe company's website, which is accessible on the World Wide Web (see,e.g., the url “invisalign.com”). Examples of tooth-mounted attachmentssuitable for use with orthodontic appliances are also described inpatents and patent applications assigned to Align Technology, Inc.,including, for example, U.S. Pat. Nos. 6,309,215 and 6,830,450.

FIG. 19B illustrates a tooth repositioning system 1910 including aplurality of appliances 1912, 1914, 1916 suitable for incorporation withthe embodiments provided herein. Any of the appliances described hereincan be designed and/or provided as part of a set of a plurality ofappliances used in a tooth repositioning system. Each appliance may beconfigured so a tooth-receiving cavity has a geometry corresponding toan intermediate or final tooth arrangement intended for the appliance.The patient's teeth can be progressively repositioned from an initialtooth arrangement to a target tooth arrangement by placing a series ofincremental position adjustment appliances over the patient's teeth. Forexample, the tooth repositioning system 1910 can include a firstappliance 1912 corresponding to an initial tooth arrangement, one ormore intermediate appliances 1914 corresponding to one or moreintermediate arrangements, and a final appliance 1916 corresponding to atarget arrangement. A target tooth arrangement can be a planned finaltooth arrangement selected for the patient's teeth at the end of allplanned orthodontic treatment. Alternatively, a target arrangement canbe one of many intermediate arrangements for the patient's teeth duringthe course of orthodontic treatment, which may include various differenttreatment scenarios, including, but not limited to, instances wheresurgery is recommended, where interproximal reduction (IPR) isappropriate, where a progress check is scheduled, where anchor placementis best, where palatal expansion is desirable, where restorativedentistry is involved (e.g., inlays, onlays, crowns, bridges, implant,veneers, and the like), etc. As such, it is understood that a targettooth arrangement can be any planned resulting arrangement for thepatient's teeth that follows one or more incremental repositioningstages. Likewise, an initial tooth arrangement can be any initialarrangement for the patient's teeth that is followed by one or moreincremental repositioning stages.

FIG. 20 illustrates a method 2000 of orthodontic treatment using aplurality of appliances, in accordance with many embodiments. The method2000 can be practiced using any of the appliances or appliance setsdescribed herein. In step 2010, a first orthodontic appliance is appliedto a patient's teeth in order to reposition the teeth from a first tootharrangement to a second tooth arrangement. In step 2020, a secondorthodontic appliance is applied to the patient's teeth in order toreposition the teeth from the second tooth arrangement to a third tootharrangement. The method 2000 can be repeated as necessary using anysuitable number and combination of sequential appliances in order toincrementally reposition the patient's teeth from an initial arrangementto a target arrangement. The appliances can be generated all at the samestage or in sets or batches (e.g., at the beginning of a stage of thetreatment), or one at a time, and the patient can wear each applianceuntil the pressure of each appliance on the teeth can no longer be feltor until the maximum amount of expressed tooth movement for that givenstage has been achieved. A plurality of different appliances (e.g., aset) can be designed and even fabricated prior to the patient wearingany appliance of the plurality. After wearing an appliance for anappropriate period of time, the patient can replace the currentappliance with the next appliance in the series until no more appliancesremain. The appliances are generally not affixed to the teeth and thepatient may place and replace the appliances at any time during theprocedure (e.g., patient-removable appliances). The final appliance orseveral appliances in the series may have a geometry or geometriesselected to overcorrect the tooth arrangement. For instance, one or moreappliances may have a geometry that would (if fully achieved) moveindividual teeth beyond the tooth arrangement that has been selected asthe “final.” Such over-correction may be desirable in order to offsetpotential relapse after the repositioning method has been terminated(e.g., permit movement of individual teeth back toward theirpre-corrected positions). Over-correction may also be beneficial tospeed the rate of correction (e.g., an appliance with a geometry that ispositioned beyond a desired intermediate or final position may shift theindividual teeth toward the position at a greater rate). In such cases,the use of an appliance can be terminated before the teeth reach thepositions defined by the appliance. Furthermore, over-correction may bedeliberately applied in order to compensate for any inaccuracies orlimitations of the appliance.

Appliance fabrication or design can make use of one or more physical ordigital representations of the patient's teeth. Representations of thepatient's teeth can include representations of the patient's teeth in acurrent arrangement, and may further include representations of thepatient's teeth repositioned in one or more treatment stages. Treatmentstages can include a desired or target arrangement of the patient'steeth, such as a desired final arrangement of teeth. Treatment stagescan also include one or more intermediate arrangements of teeth (e.g.,planned intermediate arrangements) representing arrangements of thepatient's teeth as the teeth progress from a first arrangement (e.g.,initial arrangement) toward a second or desired arrangement (e.g.,desired final arrangement).

FIG. 21 illustrates a method 2100 for digitally planning an orthodontictreatment and/or design or fabrication of an appliance, in accordancewith many embodiments. The method 2100 can be applied to any of thetreatment procedures described herein and can be performed by anysuitable data processing system.

In step 2110, a digital representation of a patient's teeth is received.The digital representation can include surface topography data for thepatient's intraoral cavity (including teeth, gingival tissues, etc.).The surface topography data can be generated by directly scanning theintraoral cavity, a physical model (positive or negative) of theintraoral cavity, or an impression of the intraoral cavity, using asuitable scanning device (e.g., a handheld scanner, desktop scanner,etc.).

In step 2120, one or more treatment stages are generated based on thedigital representation of the teeth. The treatment stages can beincremental repositioning stages of an orthodontic treatment proceduredesigned to move one or more of the patient's teeth from an initialtooth arrangement to a target arrangement. For example, the treatmentstages can be generated by determining the initial tooth arrangementindicated by the digital representation, determining a target tootharrangement, and determining movement paths of one or more teeth in theinitial arrangement necessary to achieve the target tooth arrangement.The movement path can be optimized based on minimizing the totaldistance moved, preventing collisions between teeth, avoiding toothmovements that are more difficult to achieve, or any other suitablecriteria.

In step 2130, at least one orthodontic appliance is fabricated based onthe generated treatment stages. For example, a set of appliances can befabricated to be sequentially worn by the patient to incrementallyreposition the teeth from the initial arrangement to the targetarrangement. Some of the appliances can be shaped to accommodate a tootharrangement specified by one of the treatment stages. Alternatively orin combination, some of the appliances can be shaped to accommodate atooth arrangement that is different from the target arrangement for thecorresponding treatment stage. For example, as previously describedherein, an appliance may have a geometry corresponding to anovercorrected tooth arrangement. Such an appliance may be used to ensurethat a suitable amount of force is expressed on the teeth as theyapproach or attain their desired target positions for the treatmentstage. As another example, an appliance can be designed in order toapply a specified force system on the teeth and may not have a geometrycorresponding to any current or planned arrangement of the patient'steeth.

The appliance set may include one or more of the mandibular advancementappliances described herein. As discussed, the appliance can be designedto reduce or prevent unintentional tooth repositioning while includingcavity geometries selected to elicit the tooth movements specified bythe corresponding treatment stage. At least some of these properties canbe determined via suitable computer software or other digital-basedapproaches. For example, computer modeling strategies can be used todetermine suitable force systems including one or more forces and/ormoments to be applied to the teeth in order to elicit the desired toothmovements and/or prevent unwanted movements, while producing a targetedamount of mandibular advancement. The geometry of the appliances (e.g.,geometry of the shell, teeth receiving cavities, advancement structures,etc.) can be digitally designed based on the determined force systems.The digital models created using such methods may be used as input to acomputer-controlled fabrication system for fabricating appliances.

As illustrated by the dashed line in FIG. 21, design and/or fabricationof an appliance, and perhaps a particular treatment plan, may includeuse of a representation of the patient's teeth (e.g., receive a digitalrepresentation of the patient's teeth 2110), followed by design and/orfabrication of an appliance based on a representation of the patient'steeth in the arrangement represented by the received representation.

FIG. 22 is a simplified block diagram of a data processing system 2200that may be used in executing methods and processes described herein.The data processing system 2200 typically includes at least oneprocessor 2202 that communicates with one or more peripheral devices viabus subsystem 2204. These peripheral devices typically include a storagesubsystem 2206 (memory subsystem 2208 and file storage subsystem 2214),a set of user interface input and output devices 2218, and an interfaceto outside networks 2216. This interface is shown schematically as“Network Interface” block 2216, and is coupled to correspondinginterface devices in other data processing systems via communicationnetwork interface 2224. Data processing system 2200 can include, forexample, one or more computers, such as a personal computer,workstation, mainframe, laptop, and the like.

The user interface input devices 2218 are not limited to any particulardevice, and can typically include, for example, a keyboard, pointingdevice, mouse, scanner, interactive displays, touchpad, joysticks, etc.Similarly, various user interface output devices can be employed in asystem of the invention, and can include, for example, one or more of aprinter, display (e.g., visual, non-visual) system/subsystem,controller, projection device, audio output, and the like.

Storage subsystem 2206 maintains the basic required programming,including computer readable media having instructions (e.g., operatinginstructions, etc.), and data constructs. The program modules discussedherein are typically stored in storage subsystem 2206. Storage subsystem2206 typically includes memory subsystem 2208 and file storage subsystem2214. Memory subsystem 2208 typically includes a number of memories(e.g., RAM 2210, ROM 2212, etc.) including computer readable memory forstorage of fixed instructions, instructions and data during programexecution, basic input/output system, etc. File storage subsystem 2214provides persistent (non-volatile) storage for program and data files,and can include one or more removable or fixed drives or media, harddisk, floppy disk, CD-ROM, DVD, optical drives, and the like. One ormore of the storage systems, drives, etc may be located at a remotelocation, such coupled via a server on a network or via theinternet/World Wide Web. In this context, the term “bus subsystem” isused generically so as to include any mechanism for letting the variouscomponents and subsystems communicate with each other as intended andcan include a variety of suitable components/systems that would be knownor recognized as suitable for use therein. It will be recognized thatvarious components of the system can be, but need not necessarily be atthe same physical location, but could be connected via variouslocal-area or wide-area network media, transmission systems, etc.

Scanner 2220 includes any means for obtaining a digital representation(e.g., images, surface topography data, etc.) of a patient's teeth(e.g., by scanning physical models of the teeth such as casts 2221, byscanning impressions taken of the teeth, or by directly scanning theintraoral cavity), which can be obtained either from the patient or fromtreating professional, such as an orthodontist, and includes means ofproviding the digital representation to data processing system 2200 forfurther processing. Scanner 2220 may be located at a location remotewith respect to other components of the system and can communicate imagedata and/or information to data processing system 2200, for example, viaa network interface 2224. Fabrication system 2222 fabricates appliances2223 based on a treatment plan, including data set information receivedfrom data processing system 2200. Fabrication machine 2222 can, forexample, be located at a remote location and receive data setinformation from data processing system 2200 via network interface 2224.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. Numerous differentcombinations of embodiments described herein are possible, and suchcombinations are considered part of the present disclosure. In addition,all features discussed in connection with any one embodiment herein canbe readily adapted for use in other embodiments herein. It is intendedthat the following claims define the scope of the invention and thatmethods and structures within the scope of these claims and theirequivalents be covered thereby.

What is claimed is:
 1. An intraoral orthodontic appliance for treatingsleep apnea in a patient by displacing a lower jaw of the patientanteriorly relative to an upper jaw of the patient, the intraoralorthodontic appliance comprising: a first appliance shell comprising afirst plurality of cavities shaped to receive teeth of a jaw of thepatient, wherein the first appliance shell comprises a first advancementstructure arranged to interact with an opposing jaw of the patient so asto displace the lower jaw anteriorly relative to the upper jaw, andwherein the first plurality of cavities comprises cavity geometriesshaped to reduce repositioning of one or more received teeth elicited bydisplacement of the lower jaw anteriorly relative to the upper jaw, thecavity geometries further being shaped to reposition the patient's teethtowards a target arrangement; and a coupling on a surface of the firstadvancement structure configured to mate with a coupling of a secondappliance shell.
 2. The appliance of claim 1, wherein the cavitygeometries are shaped to apply a non-uniform force distribution on theone or more received teeth.
 3. The appliance of claim 2, wherein thenon-uniform force distribution comprises an amount of force applied toone or more posterior teeth that is greater than an amount of forceapplied to one or more anterior teeth.
 4. The appliance of claim 3,wherein the first plurality of cavities comprises one or more posteriorcavities shaped to receive the one or more posterior teeth, and whereinthe one or more posterior cavities comprise a position different from aposition of the one or more posterior teeth.
 5. The appliance of claim3, wherein the cavity geometries comprise a gap between an inner cavitywall and a surface of the one or more anterior teeth.
 6. The applianceof claim 1, wherein the first plurality of cavities is shaped to receiveat least one anterior tooth, and wherein the cavity geometries areshaped to reduce repositioning of the at least one anterior toothelicited by the displacement.
 7. The appliance of claim 6, wherein theat least one anterior tooth comprises an anterior tooth of the lower jawand the cavity geometries are shaped to reduce anterior flaring of theanterior tooth of the lower jaw elicited by the displacement.
 8. Theappliance of claim 6, wherein the at least one anterior tooth comprisesan anterior tooth of the upper jaw and the cavity geometries are shapedto reduce retraction of the anterior tooth of the upper jaw elicited bythe displacement.
 9. The appliance of claim 1, wherein the secondappliance shell comprises a second plurality of cavities shaped toreceive teeth of the opposing jaw.
 10. The appliance of claim 9, whereinthe first advancement structure interacts with the opposing jaw viaengagement with a second advancement structure of the second applianceshell.
 11. A method for producing an intraoral orthodontic appliance fortreating sleep apnea in a patient, the method comprising: determining,with aid of one or more processors, a geometry of a first applianceshell comprising a first plurality of cavities shaped to receive teethof a jaw of the patient, wherein the first appliance shell comprises afirst advancement structure arranged to interact with an opposing jaw ofthe patient so as to displace the lower jaw anteriorly relative to theupper jaw, and wherein the first plurality of cavities comprises cavitygeometries shaped to reduce repositioning of one or more received teethelicited by displacement of the lower jaw anteriorly relative to theupper jaw and wherein a coupling on a surface of the first advancementstructure configured to mate with a coupling of a second applianceshell.
 12. The method of claim 11, wherein the cavity geometries areshaped to apply a non-uniform force distribution on the one or morereceived teeth.
 13. The method of claim 12, wherein the non-uniformforce distribution comprises an amount of force applied to one or moreposterior teeth that is greater than an amount of force applied to oneor more anterior teeth.
 14. The method of claim 13, wherein the firstplurality of cavities comprises one or more posterior cavities shaped toreceive the one or more posterior teeth, and wherein the one or moreposterior cavities comprise a position different from a position of theone or more posterior teeth.
 15. The method of claim 13, wherein thecavity geometries comprise a gap between an inner cavity wall and asurface of the one or more anterior teeth.
 16. The method of claim 11,wherein the first plurality of cavities is shaped to receive at leastone anterior tooth, and wherein the cavity geometries are shaped toreduce repositioning of the at least one anterior tooth elicited by thedisplacement.
 17. The method of claim 16, wherein the at least oneanterior tooth comprises an anterior tooth of the lower jaw and thecavity geometries are shaped to reduce anterior flaring of the anteriortooth of the lower jaw elicited by the displacement.
 18. The method ofclaim 16, wherein the at least one anterior tooth comprises an anteriortooth of the upper jaw and the cavity geometries are shaped to reduceretraction of the anterior tooth of the upper jaw elicited by thedisplacement.
 19. The method of claim 11, further comprisingdetermining, with aid of the one or more processors, a geometry of thesecond appliance shell comprising a second plurality of cavities shapedto receive teeth of the opposing jaw.
 20. The method of claim 19,wherein the first advancement structure interacts with the opposing jawvia engagement with a second advancement structure of the secondappliance shell.